Pfizer

CAREGIVER RECEIVED FIRST VACCINE DOSE AND SOON AFTER BEGAN TO FEEL DIZZY AND HER EYES BEGAN TO TWITCH, FOLLOWED BY UNCONTROLLED SHAKING, WITH HIGH FEVER FOLLOWED BY SEVERE SHORTNESS OF BREATH AND GASPING, WITH TIGHTNESS AROUND THE CHEST. TRANSPORTED TO EMERGENCY DEPARTMENT. HAD MULTIPLE EPISODES OF ITEMS LISTED ABOVE WHILE IN ED, INCLUDING HEAVINESS IN HER LEGS AND TINGLING IN ARMS. SHE WAS DISCHARGED FROM ED AT 10:30PM BUT WAS READMITTED ON 12/24 TO ED FOLLOWING SIMILAR ISSUES. TO DATE SHE HAS HAD 5 RAPID RESPONSES IN HOSPITAL DUE TO REPEAT OF SIGNS/SYMPTOMS. CT AND PULMONOLOGY CONSULT SCHEDULED FOR 12/28/2020.

Rash throughout scalp, face, neck, ears,torso,thighs,legs, arms, back, itchy throat and ears. Benadryl 50 mg Pepcid 40 mg Prednisone 60 mg The rash started after 1 hour. Took 25 mg benadryl then by 9 pm it got worse, took another 25 mg benadryl without improvement. Continue taking benadryl next day and took pepcid by 12 noon the next day. Following day 22nd December the patient went to hospital ER at 1200 noon. There got prescribed 60 mg prednisone PO with benadryl 50 mg and pepcid 20 mg. Received instructions to continue taking same dose for another 4 days.

Approx. 3 hours after being vaccinated. Developed confusion, dizziness, and blurred vision. Went to ER. BP noted to be 163/100. After one hour and a half, BP in the 120's systolic and 90's diastolic. Continued to have blurred vision. Blood pressure became labile and continued to be in the range of 160's over 100's to 130/90's. After 48 hours, vision no longer blurred, Blood pressure returned to normal baseline and maintained. Took BP for over one week after, morning, noon, and night on the Left arm and Right arm. My BP stayed in the 117/70-120/80 range. Wanted to make sure I had no underlying hypertension. No other adverse issues.

Numbness and tingling (similar to a pins and needles sensation when a limb fall asleep) in my left hand/fingers and the left side on my lip; Numbness and tingling (similar to a pins and needles sensation when a limb fall asleep) in my left hand/fingers and the left side on my lip; Numbness and tingling (similar to a pins and needles sensation when a limb fall asleep) in my left hand/fingers and the left side on my lip; Numbness and tingling (similar to a pins and needles sensation when a limb fall asleep) in my left hand/fingers and the left side on my lip; This is a spontaneous report from a contactable Nurse (patient). A 40-year-old female patient (no pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (lot number: EK9231) on 23Dec2020 07:15 PM via unknown route of administration (vaccine location: Left arm), at single dose (first dose) for COVID-19 immunization. Medical history was reported none. Concomitant medications included ibuprofen. There were no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient did not use other vaccine in four weeks. Patient experienced Numbness and tingling (similar to a pins and needles sensation when a limb fall asleep) in her left hand/fingers and the left side on her lip on 25Dec2020. Patient did not receive any treatment. The outcome of the events was not recovered. This case was assessed non-serious by reporter. The events did not result in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect.

Intially started as lip numbness, then tongue, lasting for about 10-15 minutes. It went away, then about 10 minutes later her Right arm became numb, then it returned to her lips on the Right side of her mouth, and then feeling wobbly, weakness on the Right leg. Elevated blood pressure, 182/112. Got medication prescribed and is lowerin blood pressure now, within an hour of taking medication, but numbness remains.

Hives, wheezing,SOB,itching, Tingling in tongue initially. 01/05/2021 Fever 100.8, headache and joint pain Treated with Albuterol inhaler and Benadryl 25mg x2

Angioedema; This is a spontaneous report from a contactable Other Health Professional (patient). A 40-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EL1284, intramuscular in the right arm (also reported as right shoulder), first dose on 22Dec2020 00:30 at a single dose for Covid-19 immunization. The patient's relevant medical history included severe reaction to some animal dander and pollen, severe reactions to poison oak, possible drug induced reactions (unspecified) post C-section, mild rash with influenza vaccine this year (2020) (with no other hx of adverse reaction to a vaccine); had allergies to pollen, mold, some animals. The patient previously took influenza vaccine (split virion, inactivated) and experienced rash. The patient had no covid prior vaccination nor was she tested post vaccination. Adverse event reported was angioedema on 24Dec2020 with outcome of recovering. Systems started appearing on 23Dec2020 evening with slight rash and fluid collection under right eye. Developed more rash on 24Dec2020. In the evening to early morning of 25Dec2020, symptoms worsened significantly. Rapid swelling to face occurred. Swelling was concentrated around eyes and cheeks the most. Both right and left side of the face and neck were affected. However, the right side face had a more pronounced reaction. MD ordered oral prednisone and Benadryl as treatment plan. Also, ordered episode-pen for a worst case scenario. Symptoms have been improving under treatment but still persist some. The events were reported as non-serious. The adverse event start date was 24Dec2020 (as reported). The event resulted in doctor or other healthcare professional office/clinic visit.; Sender's Comments: There is a reasonable possibility that the event angioedema was related to BNT162b2 based on known drug safety profile and temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

eye pain; sensitivity to light; headache/Headache worsened/migraine; This is a spontaneous report from a non-contactable healthcare professional. A 40-year-old female patient received BNT162B2 on 29Dec2020 12:30 at left arm at single dose for COVID-19 immunization. Medical history included chronic kidney disease. Concomitant medications included labetalol, lisinopril, tolvaptan (JYNARQUE), calcium, and ascorbic acid/ferrous fumarate (VITRON C). Patient experienced headache the night on 29Dec2020 21:00 after took the vaccine. Slept the night without much trouble. Headache worsened in the morning, almost felt like a migraine attack with sensitivity to light and eye pain etc. on 30Dec2020. Treatment was not received for these events. Outcome of the events was not resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

bilateral tinnitus; This is a spontaneous report from a contactable physician (patient). A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number and expiration date were not reported, intramuscular in the arm left, first dose on 19Dec2020 09:30 at a single dose for Covid-19 immunization. Medical history included hypothyroidism. The patient previously took penicillin and had allergy with hives. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with Covid 19 nor was she tested for Covid 19. Concomitant medication included levothyroxine. The patient noticed onset of bilateral tinnitus that was constant and new since the injection. She doesn't know that it was related but it was very new in onset about 24 hrs after the vaccine and quite an obvious change. She mentioned that she is only 40 and has no known hearing loss and an ENT physician so can pinpoint no other triggers. The event resulted to a doctor or other healthcare professional office/clinic visit. No treatment received for the event. The outcome of the event bilateral tinnitus was not recovered. Information on the lot/batch number has been requested.

Patient with very mild swelling lip and itchy feeling of tongue. Given 37.5 mg Benadryl, all symptoms resolved.

Weak, nausea, hives, high fever 102.9 for 16 hours, chills, joint pain (arms, hips, legs and back), symptoms improved after 32 hours. Loss of voice at 42 hours but has since came back.

Warmth at injection site Warm all over body Itchy tingling on my lips. Same feeling I have when I eat shrimp.

Started with tingling in arms and hands within 5 minutes, then tingling in tongue, and heart racing, lead to difficulty breathing and turning pale. Staff stuck me with an EpiPen in my right thigh and EMT was called and Benadryl was administered.

Chest heaviness and pressure about 10 minutes afterwards, got better then came back multiple times that same day. I also had sore throat and funny taste in my mouth. That night is when I mainly definite effects, chills, fatigue, body aches, low grade fever and head ache. Wednesday and Thursday I was in bed with fever, nasal congestion, body aches. Friday I started to feel better and function. By Saturday I was fine. Was in communication with my PCP. My daughter, 3 years old tested positive for Covid on 1/4/2021 and now I'm starting to feel bad.

I started seeing a squiggly bright circle. It started as a spot then grew to a bright outlined circle. I also started to get a headache. I took 3- 200mg ibprofen. About 10 minutes later, the vision problem went away.

Swollen and numb upper lip; Swollen and numb upper lip; This is a spontaneous report from a contactable healthcare professional, the patient. A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EJ1685), via an unspecified route of administration in the left arm on 31Dec2020 at 12:30 PM (at the age of 40-year-old) as a single dose for COVID-19 immunization. Medical history included diabetes mellitus, high cholesterol, and hypothyroidism. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included atorvastatin (LIPITOR), metformin, sitagliptin (JANUVIA), empagliflozin (JARDIANCE), and dulaglutide (TRULICITY). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Jan2021 at 07:00 AM, the patient experienced swollen and numb upper lip. The events were reported as non-serious. The patient did not receive any treatment for the swollen and numb upper lip. The clinical outcome of the swollen and numb upper lip was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.

Tingling and numb face and lips mostly on right side of face, right ear pain, right jaw pain, right side headache, sore arm at site, nausea, dizziness, lethargic

Employee woke with sensory disturbance on left side of face itchy sensation, left eyelid and bottom lip droop, left ear pain. She was ordered steroids by her PCP.

Patient report tingling of the tongue and pain with swallowing. Right side tongue swelling and right side facial tingling with difficulty to swallow occurred 45 minutes after receiving the vaccine. Patient took 50 mg of Benadryl after 10 minutes there was improvement and after 30 minutes it completely resolved. She woke up the next morning with HA and diarrhea she took Tylenol and will monitor.

Pfizer-BioNTech COVID-19 Vaccine EUA Patient experienced tingling tongue, odd taste on her tongue and neck swelling. Actions taken: Patient stated she had her own 50 mg of Benadryl with her and had taken it at 1305. She states she has other reactions to medications in the past and it feels the same way. Patient monitored, EMS called and care transferred. Patient was alert and oriented.

After receiving injection, patient reported SOB, chest tightness, hand tremor, and seeing stars. Rapid response called , patient observed for 30 minutes and walked to car. Patient then presented to emergency department at 12:06pm with concern for reaction and h/o heart mumur as a child. Patient referred to Urgent Care Clinic and presented at 12:30, endorsed headache and anxiety. Patient received acetaminophen 1,000mg PO x 1 dose, diphenhydramine 25mg PO x 1 dose, and ibuprofen 600mg PO x 1 dose in Urgent Care. Crackers and water given. Patient provided education on managing anxiety and discharged.

Acute allergic reaction Tongue swelling Facial swelling Throat swelling Rash on throat and chest Redness in throat Diaphoresis Momentary loss of consciousness

Around at 7AM when I arrived at work I started feeling chills, took temperature 99.5F that is already elevated for me. About 9:30 my temp was 101.8F and they sent me home. I just had the chills and fever. I got home and developed a headache and around 1PM I started feeling really dizzy. The temperature did not subside and the next day I woke up and I couldn't function, I felt really dizzy I kept laying down and drinking water, I could not keep anything down my stomach did not feel well. I felt like I had to vomit. When I sat down in the toilet then my ears started ringing pretty bad all of a sudden I could not hear anything and I passed out in the toilet. My husband found me and tried to wake me up. After that I still feel dizzy. I did not have any appetite either. I could barely hold water. The next day I was not as dizzy but my stomach was still upset but I could hold some soup down but then started with diarrhea. Employee health kept calling me everyday and I did the the telehealth appt and I also had a little bit of a rash in my chest that appeared all of a sudden red like a streak. The dizziness I had for the first 4 days, diarrhea did not come until the 3rd day and I had it for 2 days and my temperature was back to normal on the 4th day. Everything started to get better (my stomach stopped feeling queezy) around the 4th day but still felt fatigued until about 12/29/2020.

bloody tongue; throwing up/puking; tongue burning two days later bloody tongue; chills; legs shaky; intense migraine; nauseous stomach; I have not been this sick; This is a spontaneous report from a contactable other HCP (patient). A 40-year-old female patient received the first dose of BNT162B2, Lot number: Ek5730, intramuscular on an unspecified date at single dose in the left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. On 24Dec2020 03:00, the patient experienced intense migraine and nauseous stomach. On 24Dec2020 07:00, she started throwing up, chills, legs shaky and her symptoms had lasted from Christmas Eve until 29Dec2020. On 27Dec2020, patient's tongue was burning and two days later she had a bloody tongue. She stated, "I have not been this sick as far as I can remember it was awful. I am a healthy person I get the flu shot and any vaccine/shot necessary and have never been sick like this". Since the vaccination, the patient had been tested for COVID-19. She had a nasal swab and SARS cov 2 RNA for which she had a negative result on 29Dec2020. Stated that the test came back negative so these reactions had to be her body fighting off the vaccine. She stated she is no longer puking, no longer shaky or chills but faithfully at 3 am she woke up and had an intense migraine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any treatment for the events. The outcome of the events "chills", "legs shaky" and "throwing up/puking" was recovered on 29Dec2020. The outcome of the other events was recovering.

1/6/21: left arm soreness and decreased range of motion around 5pm. lower extremity weakness and pain, skin sensitivity (feeling like a sunburn when touched) chills and fever (100.4) around 8pm. 1/7/21: fever (101.1), headache, dental/jaw pain around 2am. Nausea started around 6am. Fever lasted all night till around 10am. Blood pressure 138/85 and resting HR 125 and fever started again around 12pm. Chest tightness during exhalation around 2pm. Went to the Emergency Room around 2:30pm. Fever and headache returned around 8pm and gone by 10pm.

11:30 SHOT GIVEN, BY 11:40 FELT TINGLING IN LIPS AND THROAT AND HEART RATE 125 (MY RESTING HEARTRATE IS 68), BY 11:45 TIGHTNESS IN CHEST AND NECK, HEARTRATE STILL 125 RANGE, NOON: BP 154/75 (MY NORMAL IS 96/58) AND HIVES 12:10 BENADRYL (25MG) GIVEN 12:25: BP 163/78 AND ALL OTHER SYMPTOMS STILL PRESENT 1:00 SECOND BENADRYL (25MG) GIVEN 1:11: BP 158/78 1:45 HEARING TURNED MUFFLED MOVED DOWNSTAIRS TO ER SECTION AT HOSPITAL GIVEN STEROIDS, PEPCID AND WATCHED FOR ADDITIONAL TIME ON 1/9/21: STILL ON BENADRYL AND STEROIDS: WOKE UP AT 8:00 AM SORE ARM AND SLIGHT HEADACHE, 9:00 RED SPLOTCHES ON FACE, NECK AND CHEST, 11:30AM ON 1/9/21: TIGHTNESS IN CHEST AND NECK CONTINUING STEROIDS AND BENADRYL

I received my 2nd dose around 11:15am on Wednesday. Approximately 6 hours after getting the shot I started feeling tired and a couple hours after that I felt crummy and the chills started. Mine weren't nearly as bad as some others have experienced. I didn't sleep well that night and woke up with a mild headache and body aches. Approximately 10AM on Thursday I noticed I had swelling in my upper lip and later my jawline with slight numbness. My eyes started feeling puffy that evening, approximately 6:30pm, and the symptoms began to improve after taking a Benadryl around 7:15pm. The swelling and numbness didn't seem to move down towards my throat nor did I experience any difficulty breathing or swallowing. I sl

headache and jaw/tooth pain on left side only evaluated by EMTs Vital signs stable , neuros intact, lungs CTA

Immediate redness/burning of the injection site. Progressed to itchy throat/tongue and hoarse voice with persistent wheezy cough after 5 min Progressed to itchy/burning/red face/chest/ears after 10 min. Wheeled to the emergency department 20-25 minutes after injection. Had to have benadryl, solumedrol, pepcid, zofran, and an epinephrine injection to stop the anaphylaxic reaction.

This is the 2nd vaccine for the patient. She was not given another lot# for this vaccine. Patient reports nausea, feels like throat is closing, change in her voice (hoarse), patient reports a metal taste in her mouth. Flushed cheeks, facial swelling and whole body was red and flushed, reddish spotting. Also reporting headache. She is still reporting the abnormal taste and headache.

heaviness on the one/left side of her body; left ear pain; left side of tongue is sore; pain that went down from her neck to her abdomen; pain that went down from her neck to her abdomen; injection pain on left arm.; This is a spontaneous report from a contactable nurse (patient). A 40-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EJ1686, expiration date not reported), intramuscular on the left arm on 05Jan2021 at 15:00 to 05Jan2021 15:00 at SINGLE DOSE for Covid-19 vaccine. Medical history included allergies, gallbladder problems, and had a little diarrhea. Concomitant medications included famotidine (PEPCID) for any potential allergic reaction, and diphenhydramine hydrochloride (BENADRYL) for allergies, all are ongoing. On 05Jan2021, the patient experienced left ear pain, left side of tongue is sore, pain that went down from her neck to her abdomen, injection pain on left arm, and on 06Jan2021, heaviness in one/left side of the body. The patient is most concerned with the pain she is experiencing. The patient was calling about Covid vaccine and got her first shot yesterday, on 05Jan2021, around 3pm. The patient stated that they had her stay about 30 minutes to make sure no major side effects. She had gone home and noticed that her tongue on left side was swollen and persisted into the evening and had a little diarrhea. She was experiencing left ear pain and decided to lay down. She stated that when she laid down noticed that she had pain that went down from her neck to abdomen, that when she woke up this morning that she had pressure on left side of her body and everything else had gotten better. She clarified that it was not swollen but sore. She stated that the diarrhea is not related to the Covid vaccine but is because she had gallbladder problems, her gallbladder was taken out before the vaccine. She stated not pressure just heavy and that the arm was regular injection pain. She stated that the shooting pain in ears is continuous like she was getting an ear infection. She stated that the symptoms are all on her left side, she clarified pressure on left side as heaviness. Stated that the allergies were diagnosed way before Covid vaccine. The patient wanted to know if other people have experienced these side effects. She stated that left side of tongue swollen resolved overnight because she did not wake up with it. Later she clarified that her left tongue was sore. Resolved completely. She stated left ear pain started last evening, that it comes and goes. Stated that the pain that went from neck to her abdomen started yesterday evening and stopped yesterday evening. Stated her left arm is sore. Stated it is sore if she touches it and is okay if she is just sitting there. She stated that she took diphenhydramine hydrochloride 25mg in case her tongue was swollen and she was having a reaction. Stated that she took two acetaminophen (TYLENOL) before she went to bed. The outcome of the events of left ear pain and injection pain in left arm was not recovered, while pain that went down from her neck to abdomen recovered on 05Jan2021, heaviness in one side of the body recovered on 06Jan2021, the rest of the events recovered on an unspecified date. The seriousness of left arm injection pain was not provided, reporter assessed other events as non-serious. The causality for the event of injection pain to left arm was related to the suspect drug, causality for other events was unknown.

drowsiness within 1 hour swelling on upper lip (lasted about 15 minutes) occurred 4 hours after vaccine administered increased temp and bodyaches occurred approx. 6 hours after vaccination

Systemic: Chills, Systemic: Headache, Systemic: dizziness, bitterness in taste in mouth, shaky, hands cold to touch, high heart rate - 120, BP 154/89

In the early morning around 3:00 a.m. presented swelling in the eyes, numbness of the tongue, swollen mouth and tingling in the face. where it took a Benadryl at the time.

developed severe headache and tongue tingling 10' after injection: transferred to ED. sx resolved upon arrival to ED. no further intervention. - observed for 4 hrs, d/c to home

Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Mild, Systemic: blurred/vision changes, tachycardia-Medium

1330-Patient relates her mouth went dry and she became dizzy. Also c/o nausea and HA .HR 72 BP 151/104 O2-84-94%RA. Patient c/o tingling in fingers and toes 1340-Patient to ED room 18. 1545-Patient discharged from ED with dx of Vasovagal response

I received my shot at 12:15 at around 12:30 I started feeling more aware of my throat. My swallowing felt slightly off however, I was not aspirated secretions. My throat felt slightly thick and I had the sensation of wanting to clear my throat. I took a deep breath and I could breath. It started to feel like my throat was getting sore or irritated. I felt slightly warmer. I decided to wait the full 30 minutes. When I went to stand had a moment of dizziness that passed but then I felt lightheadedness for about 2 hours after the injection. My ear felt like it was warm and there was slight pressure there. My throat continued to feel irritated and still feels lightly irritated after 4 days. After about 3 hours it felt like something lifted and I felt better. That night I was really fatigued and tired. Maybe slightly cold. The next day felt fine except for the throat irritation that still persists today. The side where I received the injection my arm, shoulder, and chest area felt affected for two days after receiving injection.

within 1 hour of the injection I started to get a migraine headache with photo sensitivity and nausea. within 12 hours i had body aches and chills which resolved. after five days i have still been experiencing migraine headaches

Anxiety; Headache; Seeing stars; Chest tightness; Hand tremor; SOB; This is a spontaneous report from a contactable pharmacist. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1284; Expiration date was not reported), intramuscularly on the left arm on 06Jan2021 (10:15) at a single dose for COVID-19 immunization at the hospital. Medical history included migraines; heart murmur with surgery; grand mal seizure that has resolved; and contrast dye allergy. Concomitant medications included sumatriptan and norethindrone [norethisterone]. The patient previously took phenytoin, iodine, terconazole, tramadol and cetirizine; and had allergies with these medications. On 06Jan2021 (10:15), the patient was seeing stars; had chest tightness; hand tremor; and shortness of breath (SOB). The patient was referred to the Urgent Care Clinic due to these events. On 06Jan2021 (12:30), at the Urgent Clare Clinic, the patient had anxiety and headache. The patient had received acetaminophen, diphenhydramine, ibuprofen and water as treatment for the events, 'seeing stars', 'chest tightness', 'hand tremor' and 'shortness of breath'; and was provided with education on managing anxiety. The outcome of the events was recovered in Jan2021 for 'seeing stars', 'chest tightness', 'hand tremor' and 'shortness of breath'; and was unknown for 'headache' and 'anxiety'. The patient did not have COVID-19 prior to vaccination, and was not tested post-vaccination.

Received the COVID-19 Pfizer-BioNTech vaccination at 8:40pm at a stadium location. Around 8:57, I had a metallic taste in my mouth and the left side of my tongue went numb. A little later the left side of my face felt weird and the inside of my ear felt numb. It wasn't tingling, but it felt like I had a Novacaine shot (like when you get a filling at the dentist). My neck got stiff and I was really tired. The symptoms lasted about 4 hours. When I woke up this morning the left side of my face and jaw still do not feel 100%. My left eye is watery. I'm very tired.

employee reports LOC for approx. 10-15seconds witnessed by family member who states her eyes rolled back and she began to drool. she has a history of passing out when not feeling well or vaccine. Eval in ED, treated with benadryl IV and fluids. D/c home.

Within 6 minutes I had a metalic taste in my mouth, the roof of my mouth went numb, my tongue started to swell up, the inside of my mouth started to swell up. I lost sense of taste to even water. I was allowed to take my 50 mg of benedryl. My BP was 171/100. I was taken to the ED and that is where I received the vaccine as well.

after first dose developed fever 101, shaking chills, anorexia, malaise, and myalgias. Lasted 2.5 days. Eye pain and pressure

1day after my vaccine I had fever, body aches, headache. 13 days after this vaccine my sense of smell and taste are almost gone. I also had this happen also 12 days after my 1st vaccine and both my COVID swabs were negative then.

Hypertensive Emergency (BP 219/114) with no previous blood pressure issues; Radiating chest pain, left arm pain; jaw pain; This is a spontaneous report from a contactable other Health Professional (patient). A 40-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EX5170), via an unspecified route of administration on 16Dec2020 15:00 at single dose in left arm for covid-19 immunization. Medical history included symptomatic PVC's (Premature ventricular contractions), tachycardia, bradycardia, CVA (cerebrovascular accident) from 2018 to an unknown date, asthma and rhythm. Concomitant medication included flecainide, spironolactone, metoprolol for rhythm. The patient had known allergies included hydrocodone bitartrate, paracetamol (VICODIN), eletriptan and adhesive. Prior vaccination, the patient had no covid. On 22Dec2020 18:00, the patient experienced hypertensive Emergency (BP 219/114) with no previous blood pressure issues. Radiating chest pain, left arm pain, and jaw pain. Admitted to the hospital where an echocardiogram and angiogram was performed showing clear coronary arteries and no hypertensive remodeling of the heart. Issue has been ongoing since, despite interventions. The events result in emergency room/department or urgent care and hospitalization from an unspecified date for 1 day. The patient received the treatment for the events included frequent nitroglycerin, hydralazine and metoprolol. The patient underwent curative-SARS-Cov-2 Assay RT-PCR on 01Jan2021 with negative result. The outcome of the events was not recovered.; Sender's Comments: Based on the information available, contributory role of BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE,) to event "hypertensive emergency (BP 219/114) with no previous blood pressure issues" cannot be excluded. The events chest pain and pain in jaw are attributed to underlying medical conditions and assessed unrelated. BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE,). The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Shingles: Redness and tenderness in right eye area at 7:00 PM on 1/14/21, later that nigh (approximately 11:00 PM) experienced sharp pain behind right eye. On 1/15/21 bumps in right eyebrow and itchiness on right side of scalp. on 1/16/21 developed redness in right eye. Pain behind right eye and itchiness persisted for >5 days. Went to Urgent Care on 1/20/21 and shingles suspected. Referred to confirm diagnosis. Antiviral pills and drops prescribed, as well as steroid drops.

I received the first dose in the morning and by the evening my mouth (lips, area around lips, roof of mouth, tongue) feel numb. It is a little better, however, I still have numbness around my mouth and tongue. I don?t know if I should receive the second dose.

I begin to lose consciousness; I felt lightheaded; My face and ears got red and I begin to feel warm; My face and ears got red and I begin to feel warm; Then My whole body felt really weird; my lips went numb; Afterwards for approximately 4 hours I could barely talk or open my eyes; Afterwards for approximately 4 hours I could barely talk or open my eyes; I got red rash on my neck and chest; I felt so weak, I could not move my body!; This is a spontaneous report from a contactable Other HCP reporting for herself. A 40-years-old female patient received the second dose bnt162b2 (BNT162B2) vaccine , intramuscular in the left arm on 18Dec2020 12:15 at single dose for Covid-19 immunisation . The patient medical history and concomitant medications were not reported. On an unknown date the patient received the first dose of the vaccine. The patient experienced got red rash on my neck and chest on 18Dec2020 12:15 with outcome of recovering , felt lightheaded on 18Dec2020 12:15 with outcome of recovering , face and ears got red and begin to feel warm on 18Dec2020 12:15 with outcome of recovering , then whole body felt really weird on 18Dec2020 12:15 with outcome of recovering , lips went numb on 18Dec2020 12:15 with outcome of recovering , begin to lose consciousness on 18Dec2020 12:15 with outcome of recovering , afterwards for approximately 4 hours could barely talk or open my eyes on 18Dec2020 12:15 with outcome of recovering , felt so weak, could not move my body on 18Dec2020 12:15 with outcome of recovering. The patient was hospitalized for one day for all the reported events. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 18Dec2020 . The patient received Epipen injection, steroids, saline & Benadryl as treatment for the reported events. Information on the Lot/Batch Number has been requested.; Sender's Comments: Based on the compatible time association, the reported events are possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Heart palpitations Chills Freezing hands Chills Stomach pain Body aches Headaches Loss of focus Weak Lightheadedness Dizzy Loss of balance Tingling in lips Swollen throat

Itching; headache and body aches; headache and body aches; chest tightness; had hives; Vertigo; Nystagmus in her eyes; passing out; vomiting/puke when vertical; Dizziness; tingling and numbness in throat and lips; tingling and numbness in throat and lips; tingling and numbness in throat and lips; tingling and numbness in throat and lips; heart rate 125; BP of 170/100; throat tightness; This is a spontaneous report from a contactable consumer (patient). A 40-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=El1283) via an unspecified route of administration at left arm on 08Jan2021 11:30 at single dose for covid-19 immunization. Vaccine was administered at hospital. Medical history included ongoing autoimmune disorder. The patient had known allergies to Amoxicillin and wasps. No family medical history relevant to events. Ongoing concomitant medication included hydroxychloroquine sulfate (HYDROXYCHLOROQUINE) for autoimmune disorder, celecoxib (CELEBREX) for autoimmune disorder, oral dimenhydrinate (DRAMAMINE), oral fexofenadine hydrochloride (ALLEGRA) and oral famotidine (PEPCID). No other vaccine in four weeks. The patient previously took flu vaccine (Expiry Date: Nov2020), tetanus vaccines for immunization. At 11:40 on 08Jan2021, the patient had tingling and numbness in throat and lips, heart rate was 125. By noon had hives and blood pressure (BP) of 170/100 (normal BP was 96/58 and heart rate was 65), chest tightness and throat tightness, the patient was given Benadryl (50mg) and monitored. No change so walked to emergency room. Given intravenous Benadryl and steroids then released the same day on 08Jan2021. The patient woke up on Saturday and shortly after hives came back, itching, chest tightness, headache and body aches. Saturday night on 09Jan2021 she went back to hospital due to continued reaction from 09Jan2021 06:00 pm until 10Jan2021 04:30 PM. The patient was admitted for heart testing then released on Sunday afternoon simply due because each doctor said they didn't know what to do. The patient slept from late Saturday night to Monday (except testing and eating at hospital), on 11Jan2021 around noon the patient took a shower and hives, itching and tingling all came back. Completely started over with reaction and started dizziness. On Tuesday 12Jan2021, primary care physician (PCP) for tests. Chest tightness started subsiding but very dizzy, puke when vertical. Wednesday: rheumatoid doctor. The patient had extreme vertigo. Other reported events: passing out, vomiting. Nystagmus in her eyes was very strong so that she got very dizzy. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care or Hospitalization. Adverse event start time also reported as 11:45 am. The patient underwent lab tests and procedures which included blood pressure 170/100 on 08Jan2021, blood test and electrocardiogram (EKG) with unknown results, heart rate: 125 on 08Jan2021. Normal BP was 96/58 and heart rate was 65. Heart and lungs examination with clear result. The patient had no Covid prior vaccination. Nasal Swab of Covid tested post vaccination on 05Jan2021 with a result of negative. Heart rate 125 recovered on 12Jan2021. BP of 170/100 recovered on 12Jan2021. Chest tightness sometimes she has episodes. She cannot walk without assistance. She stated she currently was 100% dependent on someone else. Throat tightness recovered on 11Jan2021. Outcome of other events was not recovered. She was treated at hospital with Oral and IV Benadryl and IV Steroids on 08Jan2021. On 09Jan2021 she was administered Oral Prednisone, Oral Diphenhydramine HCl (BENADRYL) and Oral Acetaminophen(Tylenol). Steroids switched from prednisone Oral to dexamethasone Oral twice daily. On 13Jan2021 she started on ondansetron (ZOFRAN) 4mg 3xday Promethazine (Fenagrin) 25 mg once at night. Information on Lot/Batch has been requested.

1:42 injection 1:58 reported tingly lip and feels funny, Benadryl 50mg given, no injection site reaction, lip and tongue unremarkable POX 99, P 78, bp 128/66 2:05 feels "funny, " dropping papers, appears nervous 2:20 DNS reported improved tingle 2:30 Dr. evaluated cleared resident to go home before Benadryl kicks in, tired. She stated "I feel fine"

Starting 6-7 hours after the vaccine I began to have the most severe ear pain that would not go away with Tylenol/ibuprofen. I was unable to get up/sit up on my own. My lumbar spine seized up and spasmed feeling like I had an acute injury. I had chills but no fever.

I developed R eye redness, pain and photophobia on 1/21 and was diagnosed with anterior uveitis. I am being treated with prednisolone drops and a dilating eye drop. My symptoms have improved significantly with the eye drops. I do not know if this is at all related to the vaccine - I have a h/o one other episode of anterior uveitis in my L eye in 2004, felt to be HLA-B27 associated - however I figure it is worth reporting just in case.

About 20 minutes after receiving her 2nd dose of vaccine, the patient developed tingling lips (no apparent angioedema), itching and warmth of the face and chest. Her face and upper chest did appear flushed. She was administered Benadryl, and her symptoms resolved after half an hour.

heart palpitations; Stated that it felt like nerves on inside of her body were reacting like bugs crawling on the inside of her skin; bad headache; Sore throat; tongue swollen; tired; weak; This is a spontaneous report from a contactable consumer reported for self. This 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via Intramuscular on 12Jan2021 on Arm Left at single dose (lot: EK9231) for covid-19 immunisation. Med history and concomitant medications were none. The patient had injection done yesterday (12Jan2021) and wanted to report symptoms. Stated that it felt like nerves on inside of her body were reacting like bugs crawling on inside of her skin 12Jan2021 at 6:30pm which calmed down at 10:00pm, bad headache 12Jan2021 at 6:30pm, sore throat, tongue felt swollen happened on 12Jan2021 after the injection, both resolved at 10:30pm. Stated that she did do Benadryl. Stated that she took another Benadryl this morning and it feels like it is wearing off and the sensation is coming back. Stated felt tired and weak on 12Jan2021. Stated felt like having palpitations and heart going too fast on 13Jan2021. Stated that she called her primary healthcare provider and was told to call Pfizer. Wanted to know if she needed to go to her doctor. Outcome of the events sore throat, tongue felt swollen was recovered 12Jan2021 10:30pm. Outcome of other events was not recovered.

Patient is a healthcare worker who received the first dose of the COVID-19 vaccine. Later that day, patient had excessive fatigue and some site injection pain. The next morning patient has loss of consciousness witnessed by husband. At the same time patient was drooling, not speaking clearly, and then eyes rolled back in her head, and passed out for a few minutes.

Both arms hurt; Fatigue; Headache that moves; Ear aches; Noises are louder; Mind goes blank while recalling information in a conversation; Feverish feeling but no fever; Heaviness of the body like moving in honey; Achiness; This is a spontaneous report from a contactable other healthcare professional (patient). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3248, expiration date not reported) via an unspecified route of administration on the right arm on 12Jan2021 18:45 at a single dose for COVID-19 immunization. Medical history included PCOS, Raynauds, PTSD; and known allergies: Sulpha, sulfites, pseudafed, penicillin, cephalosporins, bromfed, IV contrast, pineapple. Concomitant medication in two weeks included levocetirizine dihydrochloride (XYZAL), omeprazole, escitalopram oxalate (LEXAPRO), lamotrigine (LAMICTAL) and levothyroxine sodium (LEVOTHYROXIN). On 12Jan2021 08:45 PM, the patient experienced both arms hurt, fatigue, achiness, headache that moves, ear aches, noises are louder, mind goes blank while recalling information in a conversation, feverish feeling but no fever, heaviness of the body like moving in honey. Therapeutic measures were taken as a result of the events which included Ibuprofen (ADVIL) and acetaminophen (TYLENOL). The facility where the vaccine was administered was in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. Outcome of the events was not recovered.

weakness; confusion; dizziness; headache; hypotension; diarrhea; fatigue/lethargy; fatigue/lethargy; nausea; unilateral pain; photophobia x 3 days; Vomiting; This is a spontaneous report from a non-contactable Other HCP (patient). This 40-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 14Jan2021 at single dose for COVID-19 immunisation. Vaccine location was left arm. The patient was vaccinated at hospital, age at vaccination was 40-years-old. No other vaccine was received in four weeks. Medical history included migraines, IgM, and MGUS. Historical vaccine included first dose of BNT162B2 in left arm for COVID-19 immunisation. Concomitant medications included fremanezumab (AJOVY), escitalopram oxalate (LEXAPRO), and NURTEC (as reported). On 14Jan2021, the patient experienced vomiting, nausea, hypotension, weakness, unilateral pain and weakness, dizziness, confusion, headache, fatigue/lethargy, diarrhea, photophobia x 3 days. Events were recovering. No treatment was received for the event. No follow up attempts are possible; information about lot/batch number cannot be obtained.

Arm and face swelling, fever, bloodshot eyes, rapid heart rate, body pain, nausea, and headache. Took Tylenol, fluids, Benadryl, and rest.

Tingling sensation in throat 5 minutes after vaccine to 45 minutes after. Sensation didn't decrease. Went back to work at unit. Has history of anaphylaxis to certain medications and ADR to TDaP

patient reported mild tingling/burning in lower lip; symptoms did not worsen during 30 minute observation period; patient denies any additional symptoms; states that she had this same symptom after her first vaccination and that it lasted for about 1 hour

I experienced red, irritated eyes following the vaccine. Also experienced a blister likely chemosis which lasted approx 1 day.

left auxiliary Lymphadenopathy and lymphadenitis; left auxiliary Lymphadenopathy and lymphadenitis; eyelid swelling; left eye swelling; left eye swelling and tenderness; This is a spontaneous report from a contactable physician (patient). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on the left arm, on 14Jan2021 07:30 at a single dose for COVID-19 immunization. Medical history included seizure, COVID prior to vaccination and penicillin allergy. Patient was not pregnant at the time of vaccination. Concomitant medication included levetiracetam (KEPPRA) and lacosamide (VIMPAT). No additional vaccines administered within 4 weeks before the vaccination. The patient previously took LAMICTAL and experienced allergy. The patient experienced Left auxiliary lympadenopathy and lymphadenitis, eyelid swelling, and left eye swelling and tenderness on 15Jan2021 15:00. Patient took BENADRYL as treatment for the events and was recovering. Patient had not been tested since the vaccination. Information on the lot/batch number has been requested.

She pretreated with Claritin and tums. About 20 minutes after the injection she began having tingling and numbness in her mouth that persisted all day. The following day the tingling had improved but there was residual numbness. She also noted fatigue and body aches.

Pt received first dose and stated feeling throat swelling. Monitors with vitals and called Allergy. BP WNL, Tachycardic to 106. No signs of facial edema, no difficulty breathing or swallowing, Allergy recommended to give 10mg of Zyrtec. Afterward developed tingling in mouth. Observed total of 1hr. No progression of symptoms and allowed to go home.

I got chills; mild headache and just tired. It lasted and then I got sick on the 1st; Got tested for COVID January 3rd, 2021; On January 1 mild headache; tired and very congested but then real runny nose (went back and forth). On January 2, I got a fever - 101. Took Tylenol. On January 3, I got a fever. I was taking zinc; vitamins. My doctor prescribed medicine but I only took it twice as I didn't like how it made me feel - made it feel like I had something in back of my throat. I still have headaches - they aren't going away and neither is the tiredness. Yesterday, I woke up fine - but when I was at work started feeling very tired; and headache was so bad it felt like eyes were burning. Today I had a mild headache. I was staying at a hotel until the tests for COVID came back negative. I normally don't have headaches and fatigue.

Guillain Barre Syndrome; the patient's tongue started to go numb; The initial case was missing the following minimum criteria: Unspecified adverse event. Upon receipt of follow-up information on 18Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report from contactable consumers, sibling of the patient and his wife. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1283), via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunisation. There was no medical history, Family Medical History Relevant to adverse events or concomitant medications. There were no Prior Vaccinations within 4 weeks and no additional vaccines administered on same date of the Pfizer suspect. The sibling of the patient reported the patient had an adverse event after the vaccine that he later described as Guillain Barre. The patient was hospitalized after receiving the COVID vaccine on 08Jan2021. She was admitted to the hospital, the consumer (the sibling's wife) thought, on either 14-15Jan2021. She was not sure of the admitting diagnosis but patient was being treated for Guillain Barre Syndrome. Patient has had a spinal tap on an unspecified date, no results were known. The patient was very healthy, in general the consumer knew she had no typical comorbidities. The reason it was thought to be related was she was perfectly healthy prior and right after she got the vaccine, the patient's tongue started to go numb, that day or the day after (in Jan2021). The events required a visit to Emergency Room, but not to Physician Office. Weight was unknown but the patient was very fit, and BMI (Body mass index) had to be in the normal range. The outcome of the events was unknown.

Left side facial numbness and tingling. tongue numbness. left eye blurred vision. Symptoms stayed active for 24-48 hours

angioedema of face, feet and hands. severe headache started 30 mins after injection, noticed swelling of eyes 1 hour after injection. less than 12 hours later, full facial swelling, hands and feet. continued to worsen for the next 5 days. swelling started to slightly subside day 5. fever until day 4. vomit day 3. chills until day 4. severe headache until day 18.

December 28,(before the vaccine) I was exposed to COVID at work. I started feeling feverish on Monday at work. I needed to use my inhaler twice that day. I couldn't stop coughing at work. At home that night - used inhaler again and I had an elevated temperature - 99. something is high for me. I missed work on Tuesday. Couldn't breathe and it hurt my chest to breathe. My temp was over 100. Dr appt - went to it late afternoon he wanted me test for COVID. Took vitals - mostly normal - temp.; checked OXYGEN - normal. COVID test - was positive. Temperature went to 101 that night - couldn't breathe good - couldn't stop shaking; I was aching and I was in pain; I couldn't feel warm enough. Tried to sleep and drink fluids. Still didn't have test results from COVID test on Thursday - temp was up to 102 now. The doctor said they couldn't do anything until they had results back of test. Friday - 101 and 102.8 - temperature that day. After hours clinic - I called them - Dr - I had to gasp for every breath and I was coughing a lot. He prescribed Benzymidate - cough pearls and Azithromycin - started taking those that night. By Sunday afternoon, my fever continued and I still didn't have COVID results yet. My mom took me to Urgent Care on Sunday - still running fever; he looked at my lungs and listened - he could hear wheezing and crackling in my lungs - he determined pneumonia - he didn't know what kind - he gave me Augmentin - he told me to use both my Albuterol inhaler and steriod haler; Mucinex expectorant twice a day; Vit C and Vit D and Elderberry and Tylenol and two antibiotics. Saturday - before I went to Urgent Care on Sunday - I noticed I couldn't smell. Monday is when I got the positive test for COVID. Provided info to work and I tried to figure out how to work. Even though I was still very sick, I worked again online on Monday. But I couldn't keep working - got really whoozy; coughing and gasping felt like I was going to pass out and felt like I could hardly breathe. My mom called 911 for me. I managed to get to the bathroom - but having trouble breathing and I almost threw up - heard ringing in my ears and room was spinning. There is a lot of things after that I don't remember - when they moved me to ambulance to hospital bed I realized I had an IV in me. They stabilized me. They let me go home. I took the rest of the week off from work. Took a lot of medication and was keeping up with my vital during that week - 99.8 - 102.8 - for ten days I ran that fever. Broke Jan 20th. I went back to work on Jan 25. Still had to use an inhaler a lot. I'm slowly getting taste back; I can't taste flavor but can taste salt . I'm slowly getting smell back. I still have a lot of congestion but not as bad. Ears were bothering me this weekend so I did go to urgent care on they put me on a third antibiotic for an ear infection. Gave COVID to my son and my mother. Still have trouble catching me breath. January 23 - my isolation was extended to . the county extended my isolation period because of my family getting COVID. I'm about 75% recovered, I'd say.

Swollen face, eyes lids, nose and lips. Received the vaccine on 1-11-21. Experienced left arm numbness and pain on site. Numbness subsided and pain was minimal. Went to bed and work up around 6am to face, eyes, nose and lips swollen. Barely unable to open eyes. Immediately contacted employer employee health and contacted PCP. Appointment scheduled with PCP. PCP assessment completed. Recommended prednisone for swelling. Unable to take because of previous reaction. Recommended for Benadryl to be taken every 4-6 hrs and also Ibuprophen

Shingles: Approximately 3 hours after receiving vaccine, experienced redness and tenderness under eyebrow of right eye.; Tenderness under eyebrow of right eye/pain behind right eye that did not go away for more than 5 days; Shingles: Approximately 3 hours after receiving vaccine, experienced redness and tenderness under eyebrow of right eye.; This is a spontaneous report from a contactable healthcare professional (HCP). A 40-year-old female patient received first single dose of BNT162B2 (Pfizer- BioNTech, Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration (vaccine location: right arm) on 14Jan2021 16:00 for COVID-19 immunization. Vaccination facility: Hospital. The patient had no relevant history. The patient was not pregnant at time of vaccination and at the time of reporting. The patient had no known allergies. The patient did not have Covid prior vaccination. Concomitant medication (other medications in two weeks) included multivitamin (unspecified). There was no other vaccine in four weeks. On 14Jan2021 19:00, the patient experienced shingles: approximately 3 hours after receiving vaccine, experienced redness and tenderness under eyebrow of right eye. Experienced pain behind right eye that did not go away for more than 5 days. Sought medical attention and ophthalmologist diagnosed shingles on 20Jan2021. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, and Emergency room/department or urgent care. Treatment for the adverse events included antiviral medication and steroid drops. Patient was not Covid tested post vaccination. The patient had not recovered from the events at the time of reporting. Information about lot number and expiry date for the suspect product will be requested in follow-up attempts.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events herpes zoster, eyelid pain and erythema of eyelid cannot be excluded. The information available in this report is limited; information on previous occurrences of shingles, if any, would aid in case assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.

15 minutes after injection, I saw white spots and felt dizzy. The white spots in vision occurred on and off for the following 24 hours. Injection site warm to touch (compared to other arm) but without redness.

Pfizer-BioNTech COVID-19 Vaccine Patient got first dose of vaccine on 2/3/2021. After getting dose, she felt anxious, increased heart rate and had a metallic taste in back of her throat. Patient was sent to ER for evaluation at 10:27am. Patient felt better and discharged at 12:11pm

25 minutes after her vaccine, patient's tongue and lips started tingling. She said they were not swollen but she definitely had a tingling feeling. She felt as if she had difficulty swallowing and had some hives on her back. These symptoms all resolved after 3 hours. She never had trouble breathing and was able to eat her dinner.

Received second vaccine on 2/4/21 and on 2/8/21 went to urgent care for bilateral ear pressure and sinus congestion that was present since 2/7/21.

uvula was dropped very low/it was so long that it touches her tongue and/or sticks to her tonsils; top back roof of the mouth, uvula and tonsils felt tingly; migraine; light sensitivity; dry mouth; thirst; racing heart; felt very hot; felt dizzy, like how it felt when standing up too quickly, but she was already standing; sharp pain in her shoulder; This is a spontaneous report from a contactable healthcare professional (patient). A 40-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685), via an unspecified route of administration (left arm), on 31Dec2020 13:30, at single dose, for covid-19 immunization. Medical history included chronic migraines and depression. The patient has no known allergies. Concomitant medication included erenumab aooe (AIMOVIG), clarithromycin (CLARITIN), ibuprofen (IBU), mirtazapine (REMERON), paracetamol (TYLENOL), ascorbic acid (VIT C), and ergocalciferol (VIT D). The patient reported that "about 20 min" after receiving the vaccine, the patient's top back roof of the mouth, uvula and tonsils felt tingly. Then she started having a migraine, with light sensitivity, dry mouth, thirst, racing heart, and felt very hot. For a few seconds she felt dizzy, like how it felt when standing up too quickly, but she was already standing. Simultaneously, she had a sharp pain in her shoulder while she was dizzy. These reactions did not begin to subside until about 4 hours later. All these aforementioned adverse events happened on 31Dec2020 14:00 and the patient recovered from them on an unspecified date with lasting effects (recovered with sequel). After the tingly feeling in her mouth went away, she noticed that her uvula was dropped very low on an unspecified date. It did not look red and it was not sore, but it was so long that it touches her tongue and/or sticks to her tonsils. It has been 3 weeks later and her dropped uvula has not improved or changed. The patient did not recover from the event "uvula was dropped very low/it was so long that it touches her tongue and/or sticks to her tonsils". She added that she tried to get her 2nd dose on 22Jan2021, but the clinic and the physician did not feel comfortable with giving her the 2nd dose because they have not heard of any cases of side effects of the tingly mouth/uvula/tonsils and continued dropped uvula. No treatment was received for all the adverse events reported. The patient did not have COVID prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had the following Covid tests post-vaccination: via nasal swab on 22Jan2021 with result of negative; via nasal swab with Color on 19Jan2021 with result of negative; via nasal swab on 15Jan2021 with result of negative; via nasal swab with Color on 12Jan2021 with result of negative; via nasal swab with Color on 08Jan2021 with result of negative and; via nasal swab with Color on 06Jan2021 with result of negative.

Shortly after receiving the vaccine, I felt a very slight tingle in my lips- so slight that I thought I was imagining it and so I didn't say anything. As I was driving home, I started to feel it more and also felt it in my tongue. When I got home, the only antihistimine I had was claritin, so I took that. Then, I got nervous, felt tightness in my chest and went to the ER. They gave me benadryl and that helped. I stayed in the ER for an hour to be monitored and they said everything was fine.

5 Mins into the vaccine I started to feel a sensation to my tongue. 40Mins into the vaccine my heartrate as high 120-150 I started to get really dizzy, I had shortness of breath I felt like I was getting ready to faint . I started having getting cotton mouth(Dry mouth). 8 hours post vaccine I started the heart rate went down but I started feeling like I had something in my throat . the bumps on the back on my tongue was swollen. I took Zyrtec and Pepcid Blood pressure was high Glucose was high

administration_date=22Jan2021, dose_number=2/administration_date=30Dec2020, dose_number=1; Swollen and tenderness in tongue; Swollen and tenderness in tongue; Tender gums; soreness on right side of neck under ear; This is a spontaneous report from a contactable other hcp (patient). A 40-year-old female patient received second dose of bnt162b2 (lot number: EL3246), intramuscularly at arm left on 22Jan2021 15:00 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose of bnt162b2 (lot number: EH9899) intramuscularly at left arm on 30Dec2020 15:00 for covid-19 immunisation. Not Pregnant at the time of vaccination. The patient receive no other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced swollen and tenderness in tongue. Tender gums and soreness on right side of neck under ear, from 24Jan2021 08:00 AM. The adverse event result in doctor or other healthcare professional office/clinic visit. Treatment received for the adverse event included Prednisone and Pepcid. The outcome of the events was recovering.

blurry vision, kaleidoscope vision accompanied by a headache - entire body soreness, soreness at injection site

About 5 min after receiving the injection, throat and tongue began feeling numb and tongue felt thick. 30 minutes after injection, sudden need for BM. Oral, liquid Benadryl taken. BP 120/96, HR 93, SpO2 96%.

red rash came up on her chest; upper chest muscles just below her collar bone. the pressure of the water hitting her was painful; Diarrhea; pain and stiffness in her chest that extended across her shoulders; can't seem to regulate her body temperature; laboring to breathe; joint pain; pulse and it had dropped down to 40; She has a history of tachycardia, but her pulse kept reading normal; muscle pain; inflammation; she woke up and she was itchy around her left forearm. She was really itching; couldn't really taste, things didn't really taste right to her; immediate soreness in arm; she has pain that extends up into her neck; Nausea; hasn't had much of an appetite; sweating; left hand swelling; hives on forearm; gastrointestinal issues; Fever; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the first of two reports. A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL8982), intramuscular at left arm on 21Jan2021 15:38 at a single dose for COVID-19 immunization. Medical history included Tachycardia (started about 4 years ago), Hypertension (started about 4 years ago) and Essential tremor from 2020 (she has been having symptoms for a while; finally, during the summer of 2020, she was diagnosed through a neurologist) and anxiety, all ongoing; pain, back problems and sleep disorder.Concomitant medications included ongoing Tizanidine as muscle relaxant for back problems, ongoing Metoprolol tartrate for hypertension and tachycardia, Primidone for Essential tremor and ongoing Clonazepam for essential tremors, to help her sleep, and also for anxiety. No prior vaccinations (within 4 weeks). The patient got the first COVID vaccine dose. Afterwards, she went to school and it "was downhill from there". 5 days of persistent symptoms including sweating, muscle pain, joint pain and left hand swelling. It was further reported that she had to wait 15 minutes and then she drove home which is about a 35-minute drive. So about 45 mins after receiving the vaccine, she noticed her tongue, it was more on the right side of her tongue, she can't explain the sensation. She couldn't really taste. Things didn't taste right to her. This lasted 24 hours. She woke up the next day, 22Jan2021, feeling not quite right. She took some Tylenol that morning and went on into school. She took some ibuprofen in the middle of day, it wasn't a big deal. She has a history of tachycardia, but her pulse kept reading normal. She had a drink she was drinking from lunch and she ended up having the remainder of it the last few hours of that day. At about the end of her workday, around 15:30 she was finishing the Cdrink off and she said to herself "oh that taste like a regular drink again". This tongue sensation/lack of taste resolved. At that point, she got really excited because she thought this was all that she would experience with the vaccine. She was grateful she had the chance to have the vaccine. She mentions her arm was very sore right off the bat. She experienced immediate soreness in her arm right after receiving the COVID-19. She thought when they were injecting her, it hit her bone. In fact, she joked about this with the person administering the vaccine. The person at the facility told her to rub it, it actually helps with that. This kind of soreness didn't seem like a major problem. She was still experiencing this soreness. If she is sitting on the couch sideways, with her side of her arm against the couch, she has pain that extends up into her neck. It was pretty painful. Friday, 22Jan2021 (24 hours later after receiving the vaccine), by the time she got home from work, she was really sore. She had some real muscle pain around her hips and upper thighs, both of them. The soreness extended across. It was like she had inflammation that started flaring up. She felt pretty sore that evening. It wasn't like a normal muscle soreness. She went to bed because she was pretty tired. The next morning (Saturday, 23 Jan 2021), she couldn't get off the couch. She had such bad muscle and joint pain. She slept off and on, the pain was pretty bad. Her whole body had so much stiffness and inflammation. Every muscle and every joint just hurt. She confirmed that she hasn't been able to regulate her body temperature. This has been going on since Saturday evening (23Jan2021). She stated that this wasn't normal for her. She does take medications to lower heart rate but she hadn't taken it. She was talking to her best friend about how she had been sore and slept all evening. She checked her pulse and it had dropped down to 40. Her O2 level was at 92. She didn't think it was that big of a deal. Her best friend was kind of freaking out about it. She had such pain and stiffness in her chest that extended across her shoulders, it made it difficult to breathe. She was laboring to breathe. She checked her pulse thinking maybe she was feeling anxious about it and her HR was up, but it wasn't. She states happened so bad yesterday, yesterday was worse than before. She got up on Sunday morning, 24Jan2021, and took a hot shower. When the water from the shower head hit her chest, clarified as her upper chest muscles just below her collar bone, the pressure of the water hitting her was painful. However, she was able to get up, she was moving around. Still the whole time. she had this fever-ish feeling. Her kids were telling her that they were sweating because she had the house at 76 degrees. Monday morning, 25Jan2021, she woke up and she was itchy around her left forearm. She was really itching on Friday night, but she didn't think anything about it. When she took a hot shower yesterday (25Jan2021), a red rash came up on her chest and it looked like she had hives on her forearm. She didn't know if the hot water flared that up, but she doesn't have any allergies. She also had gastrointestinal issues. She has had some nausea that has lasted the entire time since she received the vaccine. She clarifies the nausea has came and gone. She hasn't had much of an appetite. They thought she had a fever yesterday at school. It was 99. something but she had already taken Tylenol a couple hours before and she was sweating so much. She states she has also had diarrhea the last few days, clarified as the last 2 days (24Jan2021). She has already spoken to someone to report her symptoms but wasn't sure about and had question about getting the second vaccine dose. She reported having gone to Urgent care where she was told she had Post covid vaccine syndrome and that she shouldn't have a problem with the second dose. She explained she went to the urgent care yesterday, 25Jan2021. She called her doctor that morning and was told to continue to treat her symptoms and take ibuprofen and Tylenol but if she got worse, to go to urgent care. So, she went to the urgent care (Product information for the Tylenol and Ibuprofen she has been taking (Ibuprofen: UPC/NDC: not provided when probed. Lot: P142385 Expiry date: Apr2023 and Tylenol: UPC/NDC: not provided when probed. Lot: P121664 Expiry date: Sep2023). The nurse just explained (Name Withheld) was having the same exact symptoms as the patient, except it was (Name Withheld) second dose. Her symptoms were identical to the patient. The patient wasn't initially sure if it was from the vaccine or if it was her anxiety. The patient didn't feel anxious and her heart rate wasn't up. The patient told she didn't think anxiety caused her to feel like she had a fever. The school nurse looked it up and found out more symptoms kind of wax and wane. Her symptoms got much worse. On 25Jan2021, Test: Rapid COVID-19 test Result: Negative. The event immediate soreness in arm was not recovered; event couldn't really taste, things didn't really taste right to her recovered on 22Jan2021 and nausea recovered in Jan2021; and unknown outcome for the other events.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021101606 same reporter/drug, similar events, different patient

In monitoring area shortly after vaccination, patient reported to EMS observation staff she was experiencing "lip tingling." In speaking with staff during assessment, patient's symptoms progressed to c/o lower lip swelling and trouble swallowing. Redness and swelling noted around mouth and nose. IM epinephrine administered at 18:08 and 911 called for transport to hospital.

1st dose Vaccine 1/9/21; 2nd dose vaccine 2/14/21; developed hives/rash 2/15/21, resolved with Benadryl; developed chest pain, SOA, HA, jaw/teeth pain , and nausea 2/17/21; seen at Clinic 2/17/21 and sent to ED same day for eval; was d/c'd home from ED 2/17/21.

24 hours post vaccine, developed bilateral eye swelling, itchy ness full body and right orbital pain along with the feeling of my heart racing. Swelling lasted 9 hrs, self medicated with Zyrtec (Benadryl makes my heart race) . Tylenol 1000mg every 4 hrs for headache pain. Headache is still present daily. Switched to 800 Motrin every 6 hrs. Headache and lower extremity muscle pain, as well as nerve twitches and cramping still occurring 8 days post vaccine.

Symptoms started with blurred vision within 30 minutes had full double vision , dysarthria and aphasia . Went to sleep, woke up 1 hour later bc I felt like I couldn?t breath. My arms and legs were very heavy felt close to paralyzed. I was able to move but movement was very ataxic and labored. Next morning the limb heaviness was gone, double vision was gone but had blurry vision for approx three days. Still having word finding difficulty, but mild.

After first dose on 1/11/2021 employee mentioned she had sinus congestion and a head ache for 2-3 days. She also experienced numbness of her left hip and swelling of her wrist. She was seen by her PCP and they did not associate the condition with the vaccine. After her 2nd dose on 1/28 she had a slight cough for 3 day and swelling of the arm and leg. She went to urgent care on 2/19 due to swelling and pain of her arms and legs. She was prescribed gabapentin, and pain medications. Employee developed left sided facial pain paralyses and went to the ED on 2/21 diagnosed with Bells Palsy and given acyclovir, norco and she is taking antibiotics for an ear infection. Currently still symptomatic.

A fast heartbeat- Dizziness, and weakness; Numbness and tingling; The muscles of my fingers went stiff, where my thumbs couldn?t move away from my inner palms and my other fingers would not bend. I also had difficulty speaking, as if my tongue was numb or hard to move.  This lasted about an hour (15 hrs post-vaccine).

Chest tightness, after taste in mouth, palpitations, temp 98.4 degrees, BP - 122/82, Pulse - 80 (patient states vitals elevated from normal); shaking, dizzy, nausea

Headache, muscle pain, sore throat, fever, sinus pressure, difficulty focusing eyes, fatigue. Memorable symptoms began on Feb. 19th, the worst day was Feb. 20th, when I was unable to complete my usual daily activities. My symptoms have begun to improve today, Feb 23rd. On Dec. 17th, 2020 I was diagnosed with COVID19.

Following the injection, after approximately four hours later I began to feel some slight disorientation and tiredness. Later the same evening I experienced brain fog and confusion for the next several days as well as a terrible headache. Additionally my tongue felt tingly. All of these symptoms passed within several 3- 4 days following the vaccination. injection site discomfort was also a symptom.

40 y/o female who developed anaphylaxis to Pfizer vaccine. Pt first developed itchiness of throat , followed by generalized pruritus and the sensation of "throat tightening." Received epi from medical team but initially refused ER visit. Symptoms resolved but returned 15 mins later with numbness of the lips and throat, sensation of throat closing being additonal symptoms. She was agreeable to transport after the second episode.

My face began to itch around 9 pm last night. I woke this morning with a slightly swollen face and extremely itchy face even my ears. I took a antihistamine which has helped but it still itchy. It?s currently 1 pm the following day after the first dose

Started feeling lethargic and weak at 6:30pm 2/28/21. Stomach bloating, eyes burning, no appetite, then burping that tasted and smelled sulfur-like. Around 4am 3/1/21 woke up to nausea and diarrhea. Did not go to work. Slept on and off . Drank water and ate crackers. Took Immodium and it helped for a few hours. As on 7:30pm 3/1/21, I am still nauseated and have diarrhea . No energy to do any daily activities. Been laying down the entire day. Exhausted and out of breath going up the stairs to bedroom.

Sore arm, prolonged headache (possibly from the migraine I had the day I got the vaccine) Pregnant; due date June 16 2021. First pregnancy at the age of 40.

About an hour after vaccination, my throat was tingling and my heart rate went up. It came down after a bit and my throat/tongue felt slightly numb until I took a Benadryl.

taste was altered (sweet foods, not as sweet; savory food, taste bland and bitter); This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9264: expiry date: unknown) via an unspecified route of administration in the right arm, on 27Jan2021 at 14:45, at a single dose, for COVID-19 immunisation. Medical history included high blood pressure. The patient had no known allergies. Concomitant medications included metoprolol and duloxetine hydrochloride (CYMBALTA). The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. Place where vaccine was administered was reported as "other". On 27Jan2021, about 7 hours post injection, the patient's taste was altered (sweet foods, not as sweet; savory food, taste bland and bitter). A full 24 hours after first injection, taste was still altered. The event was considered non-serious. The patient did not receive therapy for the event. Outcome of the event was not recovered. The patient has not been tested for COVID-19 since vaccination.

Patient had 2 minutes left on her 20 minute post-vaccination observation and began to complain of metallic taste, tongue feeling wierd and facial itching; no SOB, no rash or redness noted; Vitals were WNL, given Benedryl 50 mg chewable and drink of water; at no time did client c/o or appear SOB, pO2 remained at 99% and vitals remained WNL; continued observation for an additional half hour and c/o subsided; client released to home.

Dizzy Friday when given shot, Chills and fever Friday night, upset stomach, headache, low grade fever on Saturday, upset stomach, headache, lowgrade fever on Sunday, Swollen lymph nodes, rash on chest/shoulders/upper back and chills Monday, Rash spread to torso, arms, legs and neck, eyes burned and left ear hurt, chills, fever was 104, resting hear rate was 120 bpm

Pt was vaccinated in facility with a 15 min observation done. Pt ambulated to car with mother at side. Pt and mother left site to go home when pt told mother "my lips feel numb". Mother drove pt back to facility and came in to tell us that her daughter was in the car and c/o mouth feeling numb. Myself, Site Leader and charge nurse went outside to car. Pt was sitting on passenger side of car A/Ox3. Denies feeling sob, headache and chest pain. V/s obtained with inital v/s b/p 118/84, HR 83 O2 98% on RA. Advice pt that we could call EMS for further evaluation. Pt refused. Wanted to go home and take benadryl if numbness presist. Verbalized understanding of risk and outcomes of monitoring any other adverse symptoms.

Histamine reaction: red, hot sweaty cheeks that became a little puffy; slightly itchy lips; red splotchy patches on parts of my legs, chest, feet (mostly toes), and hands (mostly fingers). Started with my cheeks within minutes of the shot, got worse over the next hour. It took about 4-5 hours to dissipate. But even the next day, I have been a little itchy.

lip and tongue swelling, subjective throat swelling, pruritis epi 0.5 mg IM, benadryl 50 mg IV, solu-medrol 60 mg IV, pepcid 20 mg IV

Patient received the COVID-19 Pfizer vaccine at 08:41 am on 2/28/2021. Patient began to experience tongue swelling and her throat tightening. At 9:35 AM, Diphenhydramine 50mg IM Injection was given in the Right deltoid. Diphenhydramine lot number 6124005, EXP 04/22. At 9:48 AM, Patient continued to sound and feel throat raspy and coughing, patient was given an Epi pen into her right thigh. Epi pen lot number 0FM501, EXP 05/22. Patient was also given Solu-Medrol 40mg injection into the right glute at 10:30AM. Solu-Medrol lot number DP2618, EXP 01/22.

shortness of breath, chest tightness, throat fullness within 5 minutes of administration. With CPAP support (I use this at night for my autoimmune disease), I did not require intervention. Lasted 24 hours.

After getting the shot, I walked over to the observation area a few yards away. I sat down and my vision went blurry and the room lights were too bright. I spoke with a dr about taking ibuprofen for my ankle, as I was told to only take Tylenol. The dr said that I was fine to take it. I didn?t want to ask about my vision because I was embarrassed and didn?t want to be stressing or panicking and that be the cause of my vision issues. But it didn?t subside so I checked with a nurse before leaving, about 15 mins after the vaccination and asked if I was ok and she said yes, that she only had 1 other person tell her about blurred vision. I walked to my car and the sun was so bright I had to shield my eyes. I got in the car and took my mask off. I looked in the mirror and my cheeks and chin were flushed but my skin was pale. My husband sat with me for 10 mins and then went in for his shot. At this point it had been a little over 30 mins since getting vaccinated. I FaceTimed my mom so I wouldn?t be alone. As we were talking she said my face was getting puffy and I was getting darker circles under my eyes. I got off of the phone with my mom and called my husband on FaceTime. I asked him to talk to the dr for me and let her see my face. She said my face was swollen and red and asked if I could breathe or felt like my throat was closing over or tongue was swollen. I told her no. Once again I was told I was ok and to take Benadryl. An hr or so after the 1st dose vaccination I was able to get Benadryl and Tylenol. In a 12hr period I took 2 doses of Benadryl and 2 doses of Tylenol. My face got better in 12-24hr but I still have blurred vision and light sensitivity.

Pt. c/o itching of eyes, abdomen, behind ears and sore throat. Denied SOB or chest pain. Hx of anaphylaxis to TDap and NSAIDs. Pt stated felt similar to other reactions in past. 0917 BP 175/112 and 0927 170/105. Pt. states forgot to take BP meds. 0921 Benedryl 50 mg IM given per Dr. orders. Pt. observed for 20 min and reported all symptoms subsided. Pt. released to home driven by spouse.

8 minutes after the administration of the vaccine (while in the observation area) I started to feel really off (dizzy, anxious, ringing in right ear). I ended up becoming unconscious with seizure like activity. They rushed me to the ER and kept me for 6 hours with lots of testing. XRay, blood test, CT of head, EKG, Urine test...all came back normal. Doctor said it was likely a reaction to the vaccine. I am 40 years old with no history of seizures or allergic reactions to vaccines. The week following I experienced confusion, migraines, dizziness, slow cognitive processing, eye strain, word finding difficulties, and exhaustion. I had to take a week off of work to recover. This is the second week and I am still experiencing headaches and occasional dizziness/eye strain.

chest pain; loss of smell; fever; headaches; vomiting/nausea; vomiting/nausea; This is a spontaneous report from a contactable healthcare professional (patient). A 40-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 vaccine; lot number: EL9264), via an unspecified route of administration in the left arm on 30Jan2021 15:45 at a single dose for covid-19 immunization. Medical history included heart problems, migraine, anemia, asthma and unspecified allergies. The patient is not pregnant. The patient's concomitant medications were not reported. On 30Jan2021 19:00, the patient experienced chest pain, loss of smell, fever, headaches, vomiting and nausea. The patient did not receive treatment for the events. The outcome of the events was not recovered.

Pain in back started then spread to right side and chest in about a week, called doctor's office and they said to report as a side effect of COVID vaccine. That pain has lessened but not completely gone. Ear pain started on 3/7/21, ear pain lessened after 24 hours but not completely gone.

this morning she noted a red blotch on her left eye sclera. her right eye is fine. she denies rubbing her eye, foreign body, or coughing or sneezing or force. instructed not likely related but asked to call back if worsening, vision loss, or blurred vision. wash hands well after touching face. call back prn.Followed up with patient today. She said that the red blotch in her eye is still there but not as red and can tell that it is going away. It doesn't bother her. She did contact her PCP and they told her that it is likely not related. She thanked me for my call. Will close case.

A few hours after receiving my 2nd dose vaccine I got sores on my tongue. The following day I felt very fatigued, had a low fever for a couple hours, sore neck and shoulder to the injection site, sore throat, headache, light sensitivity and hazy/foggy feeling. I also had a finger feel sore and inflamed for about 5 days. It has been 1 week now and I still have major fatigue, headaches, brain fog, morning sore throat and just a feeling of ?not well?. I try to workout, but after I get so fatigued I can?t perform regular daily tasks. I have been so foggy, I can?t help my kids with their school work.

About 10 minutes after receiving the vaccine, the back of my neck started tightening badly and started getting uncomfortable. My throat then started to get dry and began breaking out with a rash on my neck and chest. This lasted about 30 minutes before the symptoms started to cease (in total 45 minutes after receiving the vaccine). Within 2 hours after receiving the vaccine, all symptoms had subsided. Treatment - at the vaccine clinic, EMTs observed me and took my vital signs. My blood pressure was slightly elevated, but did not require medical treatment. They continued to monitor me with the recommendation that I use my EPI-pen if symptoms got worse and instructed me to seek emergency medical treatment if symptoms got worse. No further treatment was sought out as symptoms all started to improve.

20 minutes post injection developed numbness of the mouth and tongue that lasted for 48 hours then resolved. Myalgias, fatigue and athralgias lasted a week and improved in 1 week in severity but intermittent athrlagias continue to occur. Over 1 month post 2 nd injection developed numbness of bilateral hands and feet and numbness of the mouth had recurred and is persistent for 6 days now.

Immediately after administer, I felt ?weird?. Almost a little light headed. As the minutes passed, I began feeling dissociated. Almost out of body, like I was under the influence. I began to struggle to answer questions and stay awake. I willed myself to stay calm and stay awake. I was given water and observed for an hour. My face began to feel numb and the roof of my mouth itchy. The ?high? feeling was eventually replaced by the feeling of being extremely tired. After and hour I was good to drive but extremely tired when I got home. About an hour after the shot I can taste a blood or metallic taste in my mouth. I still feel ?drugged? or tried.

Left arm pain between elbow and wrist, extreme nausea, pounding headache, dizziness, blurry vision, rash on face, extreme fatigue

Felt fine after the shot. Woke up feeling fine the next day and then about 2 pm my tongue felt like it was on fire and so did the fingers on my right arm. Now my whole body hurts and I feel like I?m going to throw up.

Caller states that she got her Vaccine at 2pm today. Now with a tingling sensation on her lips and an increase in salivation. Able to speak in long sentences. Instructed to increase her fluid intake, use mints to her secretions and if it worsens or she notice any lip swelling or resp distress, to report to the nearest ER. RN

Patient was advised to receive the vaccine regardless of an itchy throat with the first Pfizer Covid vaccine with some feeling like throat and tongue were swelling but EMTs on the scene administered IV benadryl with the first dose. With doctor recommendation to receive the second dose about 20 minutes after she received the second dose she started feeling her tongue have a fuzzy swelling sensation and began coughing frequently around 11 a.m.. Patient took 50 mg of Benadryl of her own immediately before the vaccine in order to counteract the same reaction from the first one. Due to increasing symptoms she received Epinephrine 0.3 mg/0.3 ml one shot at 11:09 a.m. and a second shot at 11:17 a.m. Patient began to show signs of improvement from the Epipen but not enough with one shot so she proceeded with the second one. She was able to leave the vaccine clinic to see her general practitioner that afternoon. She expressed that she felt jittery after the shots and we determined that the Benadryl liquid she had with her and took had Phenylephrine in it as well which combined with the Epinephrine was causing the shakiness. She felt stabilized but weak. Her blood pressure was 140/100 at 11:50 a.m. and 137/88 at 11:55 a.m. Her allergist and general practitioner were contacted and notified of the incident and they instructed her further to use Benadryl tonight and to contact them tomorrow about any further concerns. She reported this evening at 5:27 p.m. that she was okay and did not have any further issues or the feelings of the allergic reaction.

BlurredVision, Dizziness, Myalgia, Arthralgia, Fever, Angioedema, INJECTION SITE PAIN, SWOLLEN GLANDS Narrative: Other Relevant History:

Within 2 to 3 minutes after the shot, I experienced swelling in my throat. My glands were sore. I was monitored for 30 minutes by the nurse and as the symptoms were not getting worse she suggested I drive home and take Benadryl. It was a 45 minute drive. Halfway home (about one hour after my shot) I started experiencing itching, swollen tongue, swollen lips. I took 62.5 mg of Children?s Benadryl and met up with my husband and he drove me to the ER, arriving at about 10;15. After being there about 15 minutes some of my symptoms started going away. At about 11 a rash appeared on my chest. The ER doctors gave me Pepcid 10 mg around 1130 or so. They just charge me and recommended I follow up with my allergy doctor.

I began to feel very itchy all over my body within 30-60 minutes, I felt swollen in my hand, feet, tongue, my mouth and throat felt itchy, the itching got so bad that i had hives in some places such as my forearm and legs and skin just felt like it was on fire, I had issues breathing and felt as though someone was sitting on my chest, i have been shortness of breath since and have trouble catching my breath.. This was all that same night. The next day I had the same issues adding the sore arm of the injection site and feeling very tired all day. the next day from there am I am feeling better but am still experiencing shortness of breath, I am using my inhaler, I am still itchy but not as severe as the first night or next day. The arm tenderness has gone unless you touch the injection site and am no longer feeling over tired.

My face (cheeks) went numb. My tongue and throat started to tingle, like I was having an allergic reaction. I had taken a Claritin for allergies before I received the injection. The numbness started approximately 30 minutes after receiving the injection. It last until I took additional allergy medicine three hours after the injection.

Ringing in ears. The first time it happened I woke up and thought the sound was external, and I woke up my husband who said he didn?t hear anything. I realized at that point it?s the ringing in my ears. I hear it more at night time.

Severe headaches which resided after 2 days. On the third day, I began to experience ringing in my ears which has not resolved.

Systemic: metallic taste in mouth -Mild, Systemic: Flushed / Sweating-Mild, Additional Details: patient states that she has metallic taste in her mouth post observation of 30 minutes -- patient states she still has it upon leaving

Immediate but for 24 hrs only: bad taste in mouth elevated blood pressure/heart rate dizziness lasted two days: fever muscle/joint pain still continues: insomnia

Received vaccine around 11:40am. Around 7pm same night on 3/19/21 noticed rash to tops of both feet, with mild swelling and itching to feet and lower legs. Took 2 benadryl and went to sleep. Woke up this morning with facial swelling, eyes swollen shut. Took Claritin and states improved greatly. Reports itchiness in throat but denies difficulty breathing, throat swelling, chest pain or shortness of breath. Rash on feet/legs was gone when she woke up, still has itchy sensation to body but no rash. Patient reports improving symptoms at time of evaluation in Urgent Care, but would like to report side effect/reaction.

I developed heart palpitations, visited an urgent care, my primary care physician, the ER, and a cardiologist and have subsequently developed tachycardia with changed in position/posture. I recently developed tinninutus on 3/13 that has not resided.

The day after the shot I had numbness in my right leg and foot. Three days after the shot I woke up with the inability to taste. I can smell but no taste. ?Pfizer-BioNTech COVID-19 Vaccine EUA?

This report is in relation to acute sudden onset tinnitus in left year one day following first shot of COVID vaccination. Received first COVID vaccine shot in my left arm. I felt a bit tired and foggy but nothing too bad or out of the ordinary. Exactly 31 hours later, I was talking with my daughter when a very loud ringing noise entered my ears. It subsided slightly but then a persistent ringing -- tinnitus -- remains in my left ear. I saw an audiologist who indicated a slight dip in hearing acuity in the left ear at a higher pitch. I am currently on prednisone (20mg 1x per day) and doxycycline but it has been 4 days with no dissipation or relief. I have not suffered from tinnitus before.

Within hours of the vaccination, my ears started ringing (tinnitus) and worsened throughout the week. There has been no change, no easing of symptoms. It persists, disrupts my daily life, including increased anxiety and lack of sleep. In addition to the ringing, my ears feel full and hurt. I've been to 3 doctors (PCP, Allergist, ENT) since Thursday March 18, and no one has been able to help me or offer much advice. In addition to ear issues, I have loss of appetite, nausea, and diarrhea that also persist. Odd sensations in my head, like shooting pains or soreness, also occur.

About ten days after the vaccine, I got Iritis in my left eye. I noticed some blurriness and my eye was painful and got worse over the course of three days. I went to the eye doctor and they diagnosed Iritis in my left eye. Sensitive to light and darkness and it was very painful. I was prescribed Steroids and it took two weeks before my vision improved and the pain was lessened. It took six weeks of Steroids before the condition was resolved. No symptoms after the second dose.

Numbness in left cheek, occasionally to left eye lid to upper left lip. Numbness comes and goes. Currently still feel numbin face.

Pt presented to the medical tent with complaints of tingling in her tongue. States has long history of allergies, has 2 epi pens with her and premedicated herself prior to coming to the vaccination site with 50 mg of PO benadryl at 1100. As pt was monitored she developed a rash on neck that was splotchy, flat, red. Tongue tingling stopped and moved to her fingers. BP was 152/90, other VS were WNL. Seen by MD on site. 1252 pt was feeling better, rash gone, all tingling gone. Pt left on own from vaccine site.

Throat stated to felt tight, lightheaded. Pt had COVID November 2020. More swollen under chin area and lymph nodes. Patient states her mouth feels dry.

2.5 hours after vaccination, I was sitting watching tv when I had a sudden neurological event. It was like a seizure. I was unable to talk, my eyes rolled back, and my right shoulder and arm seized up. I was sputtering and unable to make it stop. Lasted for a minute or two then stopped for a minute and happened again. I felt disoriented, confused, scared. I was unable to walk straight or visually focus on anything. I contacted my primary care doctor and she recommended I be seen immediately but advised I call Providence and speak with a nurse. I did that and the nurse said to come in to the ER immediately. I did.

03.15.2021 1:40 vaccinated 1:55 left site, returned home ~3:00 began itch around waistband. Aleve for back. 3:30-4:00 symptoms undeniable: itch on neck, face, trunk, lips tingle/swell, lump in throat. Hoarse. No hives. 4:00 Claritin 4:30 talk to Dr take vitals (Sp02 100%, heartbeat normal, BP 131/79, pulse 67, temp normal) 5:15 Benadryl 5:30 itch spreads to whole body, including legs 6:30 talk to Dr Symptoms steady now. 7:30 fall asleep from Benadryl 8:30 wake up for dinner 9:30 laying in bed, breathing becomes shallow. O2 and bpm still normal. 10:00 Talk to Dr. Advises ER if vitals outside of norm. Report to PCP in am. 11:00 breathing normalizes. Sp02 and bpm normal, BP 122/82, pulse 70. Aleve before bed. midnight-1:00 fall asleep 03.16.2021 7:20 Wake up. Water, Wellbutrin, Aleve. Read in bed about an hour until fall back asleep. 11:15 Wake up. Headache. Sp02, bpm, temp, normal. Stay in bed. 12:25 Send report to Dr. 12:30 Get out of bed for first time; coffee, bathroom. Back to bed. 1:10 Spoke with triage nurse. Concern is that lips are still swollen at almost 24 hours. Recommends urgent care for steroids if increased lip/face or respiratory symptoms. Can take Claritin an hour early. 2:30 Get out of bed and shower. Warm to wash, cool to rinse. Got dressed, moved around. Increased itching, skin mottled; still no hives. Aleve. 3:00 Claritin, call from Dr nurse. 3:30 Heat up late lunch, continue to move around the house, answer work questions. 4:30 Upticked symptoms not abating, still mottled skin, lips more swollen. Harder to swallow and dry cough starts, worse when talking. Take vitals: Sp02 and bpm normal, BP 107/83, pulse 73 5:00 Leave for urgent care; BP there 159/71, pulse 79, temp normal. No steroids. Referral to allergy/immunology. Prescription H2 inhibitor, switch to Zyrtec in am. 6:40 Pepcid. Back in bed. 11:30 Benadryl, Aleve. 12:40 Sp02, bpm normal 1:15 Fall asleep 03.17.2021 8:55 Wake up. Water, Wellbutrin, Aleve. 9:30 Sp02, bpm normal. Get up for Pepcid, Zyrtec, bathroom then back in bed. 11:20-11:40 Dozed off, woken up by heart symptoms. Palpitations, panic feeling. Sp02, bpm normal 12:45 Dr called. Allowed to switch back to Claritin tomorrow. Recommends Benadryl more often. Allergy: 504.842.6742 Dr 3:00 Aleve. BP 117/80 pulse 75 4:15 Benadryl 8:20 Hoarse again 9:20 Pepcid. Itching increasing as Benadryl wears off. 10:20 Benadryl 10:30 BP 103/77, pulse 73. Sp02, bpm normal, PI 2.5% 11:45 Aleve 12:00 itching increasing as move around/get ready for bed 1:15 Fall asleep 12.18.2021 6:30 Benadryl. Tired, itch still present (improving), headache. Fell back asleep 7:30. 8:55 Water, Wellbutrin, Aleve, Claritin, Pepcid. Fell back asleep until 11:30 11:45 Sp02, bpm normal, PI 8.0 2:00 Finished shower, didn't worsen itch. 2:45 Aleve 6:00 Been "on" for work about 4 hours. Exhausted. Nauseated. Verge of collapse. Most itching is face/scalp and clothing seams. Lips almost normal though. 8:00 Meds definitely wearing off; face/lips symptoms increasing again. 8:30 Benadryl. Throat symptoms. Swollen lymph nodes. 9:15 Pepcid. Slight cough returned. 10:30 BP 120/85, pulse 80 (was just moving around quickly), Aleve. Itching better, throat/lymph nodes painful 12:45 Benadryl. Ibuprofen. Neck muscles hurt too. 1:15-1:30 fall asleep 03.19.2021 9:00 Water, Wellbutrin, Aleve. Throat still swollen. Itch primarily face/head, back of thighs. 9:15 Pepcid, Claritin. Sp02 normal, bpm low (51-53 back in bed), PI 4.1 3:15 Aleve. Lump in throat still impacts swallowing. Eating makes me hoarse. Neck muscles hurt. 11:00 Pepcid 12:15:Benadryl, Aleve. BP 109/76, pulse 69 2:30 fall asleep 03.20.2021 10:00 Water, Wellbutrin, Aleve. Lips swollen again. 10:15 Pepcid, Claritin 11:25 Symptoms: itching better, mostly gone from body (remains on head). Headache. Throat/neck improved. Lips still swollen. Sp02, bpm normal. PI 10.2% 6:00 Aleve. Itching only head/face. Throat/neck still symptomatic. 11:30 Aleve, Pepcid. Sp02 normal, bpm 70s. 12:15 Benadryl 1:20 Throat sore but no lump. Lymph nodes returning to normal. Still some itch head/face/neck. 1:45-2:00 fall asleep 03.21.2021 7:00 Claritin, back to sleep 11:00 Aleve, Pepcid, Wellbutrin. 5:00 Aleve 11:10 Pepcid, Benadryl. Mild itching. No lump. Throat still slightly sore. BP 113/77, pulse 69 12:20 Aleve 1:15-1:30 fall asleep 03.22.2021 9:45 Water, Wellbutrin, Aleve, Claritin, Pepcid 5:50 Aleve 10:00 Pepcid 12:15 Aleve. Minimal, occasional itching. Lips almost normal. Sp02 normal, bpm 70s 03.23.2021 9:45 Water, Wellbutrin, Aleve, Claritin, last Pepcid

11:26am mild dizziness and confusion. Roof of mouth itching 11:35am moderate to severe dizziness and confusion. Roof of mouth itching and mild tongue swelling. Saw nurse at observation site and was taken to paramedics. They took vitals and blood glucose which were normal. They gave me two shots of 25 mg of Benadryl, which helped tongue swelling but nothing helped dizziness and confusion. Agreed to go to the hospital by ambulance. By the time I was seen in the ER, symptoms resolved other than fatigue from benadryl. Discharged around 2:30pm

Classic vasovagal reaction without syncope Warmth, clamminess, dizziness, partial tunnel vision Self resolving symptoms with BP, pulse, O2 sat all within acceptable ranges with 60 minute observation No orthostasis and comfortable ambulation at discharge from observation unit

Day 2 tired, Day 3 and 4 headache, Day 5 and 6 - intermittent eye twitch with ocular migraine symptoms in right eye.

Swollen tongue, tight throat and chest, dizziness, light headedness, and nausea. Given epinephrine, Benadryl and Zofram

4 hours after the shot, I noticed that my left eyelid was a bit swollen. No pain or itchiness. Not sure when it began to swell. I didn't think much of it, until about 2 hours as I could feel that it was more swollen. I was with friends, they recommended benedryl. So, went and talked to a pharmacist. On the way there, back began to feel itchy (similar to when I have broken out in hives in the past when an allergic reaction starts). Pharmacist recommended 25 ml of liquid benedryl every 4-6 hours and increase to 30 ml if swelling remains. After 1-2 days, if still present to go to doctor. I already have a doc office visit early Monday morning.

After 2nd Dose: 1st Day- 5pm onset: Markedly increased heart rate while sitting at rest. Fever, fatigue, intense muscle weakness & achiness, felt like weights in my veins. Sleep overnight was disrupted often. Intense strange dreams, perhaps lucid. 2nd Day- 9am: Fever & weakness subsided, muscles remained achy particularly with increased activity. Tiredness. 3pm: Fever returned. 5pm: Strong heart palpatations. Achy muscles. 8pm: Tiredness. Strange dreams, still lucid. 3rd Day- Still slight achiness. 3pm: Intense heart palpatations, pre-menstrual cramping (11 days early, my cycle is extremely regular). 5pm: Heart palpatations, muscles felt almost an electric pulsivity. 6pm: Tooth pain for about two hours. 8pm: Vaginal discharge (clear lubricant), lasted till 3am. 4am: Urine had extremely sour smell. *3rd day indicated to me that my hormones/hypothalamus may have been affected? Very strange, out-of-cycle behaviors. I have been sexually inactive for over 6 months.

Facial numbness, loss of taste. Also note- my VARS account is not accurate & you cannot adjust you answers- it has not been doing daily checks on me - it says I?m good when still having symptoms- there is not way to contact or correct info on that system.

lips felt numb/Numbness spread throughout face/feel numb in both arms/legs started to feel numb; lips felt numb, swollen; Blood pressure was high; pulse was high; gasping for air; unable to straighten out my legs/couldn't lift her legs; ferritin levels were low; throat was closing up; unbalanced; couldn't stand up; This is a spontaneous report from a contactable consumer. A 40-year-old female patient received bnt162b2 (PFIZER), first dose at the age of 40-years-old via an unspecified route of administration, administered in arm left on 09Mar2021 13:45 (Batch/Lot Number: EN6205) as single dose for covid-19 immunisation. Medical history included hypothyroidism from an unknown date and unknown if ongoing and known allergies: sulfa from an unknown date and unknown if ongoing. Concomitant medications included rizatriptan; vitamin b complex (VITAMIN B); vitamin c [ascorbic acid]; colecalciferol (VITAMIN D); all taken for an unspecified indication, start and stop date were not reported. The patient reported within 10 minutes lips felt numb, swollen. Numbness spread throughout face, checked in with the medic and had vitals checked. Blood pressure was high, and pulse was high. Numbness spread throughout whole face. Ambulance was called and she was transported to the hospital. Within the hour of getting the shot she became unbalanced. She was gasping for air at times and started to feel numb in both arms. Upon arrival to the emergency room her legs started to feel numb. By nightfall she was unable to straighten out my legs. She couldn't stand up or lift her legs no matter how hard she tried. She was admitted to the hospital. A brain MRI was done and came back normal. Another one may be done. Bloodwork revealed ferritin levels were low and she was getting treatment for that (ferrous sulfate). While sleeping at night she woke up a few times gasping for air feeling like her throat was closing up. Today, she was able to stand up, but unable to stand up straight. She met with physical therapy and is using a walker. The patient was hospitalized for 3 days from 09Mar2021 to 12Mar2021. The patient underwent lab tests and procedures which included blood pressure measurement: high on 09Mar2021, heart rate: high on 09Mar2021, magnetic resonance imaging brain: normal on 09Mar2021, sars-cov-2 test: unknown results on 09Mar2021, serum ferritin: ferritin levels were low on 09Mar2021. Therapeutic measures were taken as a result of the events. The patient did not recover from the events.

starting nearly exactly 48 hours after vaccination: - fever: 99.5 - 101 (~48 hours) - chills (~48 hours) - night sweats (~96 hours) - fatigue (~ 7 days) - muscle aches (~7 days) - headache (~7 days) - bloodshot & swollen eyes & blurred vision (started 5 days after vaccine, got Rx for bacterial eye infection 9 days after vaccine)

On 3/10/2021 Migraine headache started at 6:15pm Ear ringing (tinnitus) started at 7:00 pm 3/11/2021 Additional hearing muffled was was noticeable 3/16/2021: severe migraine, throwing up, nauseous 3/17/2021: facial rash prominent **hearing loss deemed permanent, ringing continuous

Left Eye swelling; Severe Itching all over; Severe Headache; Stiff neck; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient she received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6198) via an unspecified route of administration in the left arm on 26Feb2021 at 16:30 (at the age of 40-years-old) as a single dose for COVID-19 immunization. Medical history included variable immune deficiency, asthma, and eosinophilic esophagitis (EOE). Allergies to medications included amoxicillin, erythromycin, clindamycin, ciprofloxacin (CIPRO), sulfamethoxazole/ trimethoprim (BACTRIM), and oxycodone/ paracetamol (PERCOCET). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications were not reported. On 26Feb2021 at 17:15, the patient experienced left eye swelling, severe itching all over, severe headache, and stiff neck. The patient was not treated for left eye swelling, severe itching all over, severe headache, and stiff neck. The clinical outcome of left eye swelling, severe itching all over, severe headache, and stiff neck was not recovered.

I received my second dose of the Pfizer vaccine on a Tuesday evening and had no adverse symptoms that night. When I woke up the next morning, I had a very, very bad headache and ringing in my ears. The headache began to subside by that night, but the tinnitus continued. By the following day (Thursday), the headache was gone but I was still tired and the tinnitus continued. By Friday, I felt basically back to normal, except for the tinnitus. It is now Tuesday, one week from the shot, and the tinnitus continues.

sore arm where shot was given; nauseous; shortness of breath; tongue tingly; right Eye bothersome; metallic taste; elevated heart rate; headache; This is a spontaneous report from a contactable consumer (patient). A 40-year-old non-pregnant female patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number: EL 3257, Expiration date: unknown) via unspecified route on 30Jan2021 01:30 PM, in the left arm, deltoid at a single dose for COVID-19 immunization. The patient's relevant medical history included asthma and seasonal allergies. Concomitant medications included Nortriptyline, oxcarbazepin, montelukost. It was reported that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the patient did not have COVID-19 prior to vaccination or tested since the vaccination. On 30Jan2021 at 02:00 PM the patient experienced very sore arm where shot was given, nauseous, shortness of breath, tongue tingly, right eye bothersome, metallic taste, elevated heart rate and headache. It was unknown if the patient had received any treatment for the events. Outcome of events was not resolved.

Fever for over 3 days, going up to 103F; severe migraines; dizziness; brain fog; loss of appetite; throat ache; ear ache; unable to get out of bed for 3 days; extremely swollen lymph nodes; This is a spontaneous report from a contactable Other Health Professional, the patient. A 40-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: EL9262), via an unspecified route of administration, in the left arm on 30Jan2021 at 10:15 AM as a single dose for covid-19 immunisation. Medical history included allergies to sulfa antibiotics. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included ibuprofen (IBUPROFEN). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: EJ1686) via an unspecified route of administration, in the left arm on 08Jan2021 at 10:00 AM as a single dose for covid-19 immunisation. On 30Jan2021 at 12:00 PM the patient exepereinced fever for over 3 days, going up to 103F, extremely swollen lymph nodes, severe migraines, dizziness, brain fog, loss of apetite, ear and throat ache, unable to get out of bed for 3 days. No treatment was given to the events. The events were assessed as non-serious by the reporter. Outcome of the events were not recovered.

Patient got her covid 19 vaccine. 5 minutes after her shot she said her throat was hot. BP was 135/90. Pulse 75. No signs of distress. I gave her 50mg of benadryl. Patient stayed for 30 minutes. All symptoms were resolved by when she left.

Anaphylactic shock. Tongue, Hands and feet swelling. Hives all over body, skin felt like it was burning from itching so bad. Inside of mouth and throat itching. Chest felt like someone was sitting on it.

Nerve pain in all of my skin (including hair follicles and teeth); extreme headache; 101 degree fever; lethargy; shivers; slept for 17 hours on and off; numbness in my face and fingers; numbness in my face and fingers; zinging pain in my teeth; This is a spontaneous report from a contactable Other HCP. This 40-year-old female Other HCP (patient) reported for herself that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number; EL9267) via an unspecified route of administration from 11Feb2021 at 03:00 pm to 11Feb2021 at 03:00 pm at single dose (dose number; 2) on left arm for covid-19 immunisation. Vaccine facility type was reported other. Patient was 40 years old and not pregnant at the time of vaccination. Patient's medical history included Known allergies: Sulfa (unspecified dates). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number; EL9262) via an unspecified route of administration from 21Jan2021 at 3:30 pm to 21Jan2021 at 03:30 pm on left arm at single dose (dose number; 1) on left arm for covid-19 immunisation. Concomitant medications included (other medications in two weeks) Ibuprofen and ascorbic acid, calcium carbonate, calcium pantothenate, calcium phosphate, chromium, cyanocobalamin, folic acid, magnesium carbonate, magnesium hydroxide, manganese gluconate, nicotinic acid, potassium bicarbonate, potassium carbonate, potassium phosphate dibasic, pyridoxine hydrochloride, quercetin, riboflavin sodium phosphate, sodium bicarbonate, sodium phosphate, thiamine hydrochloride, thioctic acid, zinc ascorbate (EMERGEN-C) and birth control from an unspecified date to an unspecified date at unknown dose and frequency for an unspecified indication. If other vaccine in four weeks; no. On 12Feb2021 at 02:00 pm, patient experienced nerve pain in all of her skin (including hair follicles and teeth), extreme headache, 101 degree fever, lethargy, and shivers. This hit her at almost 24 hours after injection. She slept for 17 hours on and off. She awoke this morning with numbness in her face and fingers, but also zinging pain in my teeth. The reported adverse events did not result in emergency room or physician's office visit. Treatment received was reported as no for the adverse events. Patient did not have covid prior vaccination and was not tested for covid post vaccination. The outcome of events was recovering.

Tightness in the chest, warmth in the chest, blurred vision and sudden drop in blood pressure to the point of almost losing the consciousness, sweat, weak pulse. The symptoms appeared at about 4 mins after the injection in the resting area. The patient was taken on the wheelchair to lay down. The pressure was taken, the EkG. The ambulance cam after 20-30 mins. The patient started recovering but still felt tightness in the chest. The patient was taken to the Medical Center. The patient was given a blood test and urine test. The patient started feeling better and was sent home after about 3-4 hours.

Dizziness, 1:30 pm, lasted 12hrs. Headache, 1:30 pm, lasted 12hrs. Tingling tongue, 1:30 pm, ongoing. Tingling roof of mouth, 1:30 pm, ongoing. Tingling lips, 1:30 pm, ongoing.

15:21-REceived vaccine injection L deltoid. 15:30-Arrived in observation area, reported onset of H/A, LUE pain and warmness, numbness of left UE and LE and dry eyes.Dr. present. 16:09-VS: 175/69; HR 80; SpO2 98%. 16:14-Epinephrine 0.3mg L lat thigh per Dr. 16:19-VS: 184/91; HR 74; SpO2 98% 16:40-VS stable, pt W/O discomfort. Released home per Dr.

Patient received Pfizer EW0150 by Nurse. Patient in observation area notified Nurse stated feeling of dizziness, flushness, numbness in tongue, throat itching and metallic taste. No audible wheezing, no shortness of breath, and no difficulty swallowing. (BP 153/99, HR, 77, Spo2: 98%) Patient with history of Asthma/Anaphylactic reactions. Allergies to Penicillin. Under observation, patient reports of improvement in condition, although still persistent throat itching and tongue numbness. 25mg Benadryl PO administered. HR: 83, BP:118/80, Spo2: 99%, patient further monitored and states feeling well with all symptoms completely resolve. Pt dc/ed educated on s/s to look out for. (HR 77, BP:112/70 O2:99%)

Patient complained lips tingling & tongue was swelling. Onsite EMS was called vitals HR 82 BP 132/87. 25 diphenhydramine was given She felt better and went home.

She got her vaccine, and within the first 15 minutes felt like her tongue was fat. The reaction started at 1:15 and her headache was getting bad and turning into a migraine, and took her migraine medicine. She was getting a stretching and painful sensation in her skin over her head. She lost her ability to swallow, and everything around her face and neck were numb. She called the hotline and called her doctor, and was able to focus very hard and able to swallow but felt very narrow passageway. She then felt like she had a bubble in her throat, and then decided to call 9-1-1. The first responders came to her house and said that they could not see anything in her throat, they gave her Benadryl and within the hour everything seemed to dissipate and they stayed with her until she stabilized. Her BP was high and her heart rate was high as well, 98-100. Her temperature was 98.5. She felt really awful and nothing was going on with her throat or breathing after the Benadryl and felt foggy and tired and by the third day she was completely fine.

9:40am injection. 10:30am migraine started. 10:40am strong ringing in my left ear, and feel dizzy. 11am spine, back, and joints hurt. Ringing in both ears, but I have lost partial hearing in my left ear. 10:22pm, still ringing in left ear, partial hearing, small headache, deep aches.

Generally occurring and resolving within 36 hours: Generalized neuropathic pain that turned gradually into generalized nociceptive pain / soreness; Pounding headache at the base of the brain; Tachycardia; Sensation of pounding heartbeats; Nausea; Sensitivity to light; Loss of appetite and thirst; Low-grade fever Still occurring at 48-53 hours: Nausea Light headache; Sensitivity to light; Some sensation of heart racing; Localized pain in different areas of the body

Patient reported throat/lip tingling and headache within 10 minutes of receiving vaccine. Patient was given benadryl and observed. Condition improved.

This was my second shot, I had no adverse reactions to the first. For 8 days after my second shot, I had a continuous headache stemming from the base of my skull. I had read this as a possible side effect so I was not concerned. On the 9th day, I woke up without a headache and thought my symptoms were over. However on that day, my sense of taste started changing. I started putting a lot more salt on things. In the following 3 days, it's progressed that anything sweet has a rancid taste. Bitter and salty items taste just fine but even plain water now tastes foul and it seems to be getting worse each day. I've never experienced this before so I am assuming it's the vaccine. At a guess, this isn't a big deal. I wouldn't be concerned except it started a week after vaccination instead of immediately. I thought it best to at least document it by informing someone.

Constant Bilateral Tinnitus, with attacking episodes multiple times a day; This is a spontaneous report from a contactable physician (patient). A 40-year-old non-pregnant female patient received BNT162B2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: EL1283) first dose via an unspecified route of administration on 29Jan2021 as single dose for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medications included iron supplement (SPATONE IRON supplement) for unspecified indication. On 14Feb2021 the patient experienced constant bilateral tinnitus, with attacking episodes multiple times a day (tinnitus) (disability). Therapeutic measures were taken as a result of constant bilateral tinnitus included prednisone taper. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient did not underwent diagnosed with COVID-19. After the vaccination patient did not tested for COVID-19. The outcome of the events was not recovered.

4am the day after my first shot I woke up to swollen, blood shot eyes which were irritated and itchy. After an hour and a half the symptoms were not getting better so I decided to take claritin since it was similar to the allergic reaction I have to mold. An hour later my eyes were better but still sore around them. The next day they were completely better. Also, since taking the vaccine I seem to forget things easily, things that I put in the microwave are sitting there the next morning which is very unusual for me to be so forgetful so many times and even at work my focus was scattered and things that were routine were becoming challenging to remember to complete. After 2 weeks it seems to have faded, although once I became aware of what was happening I have made a conscious effort to remember things. I realize that these may seem like small events, but I feel that it is something that should be looked into as it was/is rather concerning since this was only my first shot and the second is supposed to react worse. I am still contemplating whether getting a second shot is wise for me.

Pt received shot at 1145. At 1220, pt reported sx fo puffy eye lids (no puffiness visible outwardly), ears ringing, blurry vision, feeling hot, weakness in muscles. VS: BP 126/68, P85, RR18, O2 99% RA, T98.6F. Pt takes benadryl 25mg po bid. Last dose 0400 today. Pt reports multiple previous hospitalizations for congestive heart failure, tachycardia, and bradycardia. She takes ?1500 of Levothyronine? and ?Mididrine four times a day to raise my blood pressure.? She does not want more benadryl at this time. She is calm outwardly. No signs of distress noted outwardly. Diminished lung sounds in bilat lower lobes. Pt smokes cigarettes. Dr consulted. Pt advised to wait in high risk obs for another 30 min to see if symptoms resolve. After about 5 minutes, pt requested EMS. No worsening conditions noted or reported. EMS called and came to assess pt. Pt left via EMS to go to hospital at approximately 12:15pm. Pt notified to follow up with her PCP prior to second dose of vaccine.

Dizziness, tingling and itchy skin, swelling and tingling of lips and tongue, slight throat swelling. Treated at home with 50 mg Benadryl every 6 hours, Pepcid, and Predinsonl (steroid pack).

About 90 minutes after the shot, my face swelled up and had hives. My left eye would not open all the way. I had hives on my back, chest and both arms. I got the symptoms under control after 9 Benadryl pills. 2 days after the shot - my lymph nodes swelled up in my neck and on my left clavicle. I did not treat these. 3 days after the shot, out of nowhere, my left cheek swelled up and there were hives and my eye was half swollen shut. Symptoms were under control after 2 Benadryl pills. My lymph nodes remain slightly swollen, but not as severe as on Day 2.

I woke up with acute vertigo on Thursday. The room was spinning. I could not function from about 8:00 a.m. until about 6:00 p.m. I went to the doctor the next day, Friday, and was diagnosed with labyrinthitis due to allergies. I had no allergy symptoms. By Saturday, I was no longer dizzy but my ears felt full and continue to feel clogged 6 days after the onset of the vertigo.

Patient received Pfizer COVID-19 vaccine on 4/6/2021. Patient reports the following adverse reactions: facial swelling, lips swelling, reddness, small hives. Patient was given 25mg Benadryl PO per protocol. Dr was made aware. Monitored patient. Patient started to experience some throat tightness but no shortness of breath or difficulty breathing. Spoke with Dr again and gave patient 0.3mg Epinephrine in right deltoid. Dr came down to clinic as patient was going to ED per car with her sister driving. In the ED , patient was treated for anaphylaxis at hospital and stayed overnight (epinephrine, solumedrol, pepcid x2). After discharge on prednisone 40mg daily x5 days, patient came back with hives and was readmitted and treated overnight with pepcid/benadryl expect to be discharged again today.

10 mins after injection, developed tingling in mouth and lips, tightening in throat, blotchy chest and neck. arrived to obs, 1830 bp 140/69 hr 95 rr 18 sats 96%, feeling hot. water and apple juice given, started feeling relief and blotchy neck and chest improving. 1838 bp 112/66 hr 97 rr 18 sats 95% on ra. 1847 bp 118/67 hr 67 rr 20 sats 99% on ra, blotchty areas resolved, and facial/mouth tingling resolved as well as throat tightness. escorted to exit with no further issues. instructed on benadryl once home.

Patient described a swollen tongue and senation in back of throat sensation. Onsite EMS was called vitals BP 128/60. Patient recovered and went home.

both ears have a red flaky rash with small white bumps. Skin in dry to the touch and very itchy. rash has lasted 6 days at time of reporting

Seizure like events; Began sputtering; My shoulder and neck seized up; Eyes rolled back in her head and she had no control over it; Did not remember some of it; Confused; Unable to focus with her eyes; Extreme fatigue; Walking is unsteady; This is a spontaneous report from a contactable consumer (the patient). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: 59267-1000-03), via an unspecified route of administration, administered in left arm on 24Mar2021 16:45 as single dose for COVID-19 immunization. Medical history included asthma, bronchitis, anxiety, allergy to Aspirin, NSAIDs, agave, soy, and dairy. The patient has no history of COVID prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not COVID tested post vaccination. Concomitant medications included venlafaxine and progesterone taken for an unspecified indication. On 24Mar2021, 19:30, the patient experienced seizure like events. She began sputtering, her shoulder and neck seized up, eyes rolled back in her head and she had no control over it and did not remember some of it. It happened twice in a row. She had been confused, unable to focus with her eyes, extreme fatigue, and her walking was unsteady. The adverse event resulted in Emergency room/department or urgent care. The patient received treatment for the events. The patient was requested for testing and referral for neurologist for MRI. The patient has not recovered from the events. Follow up attempts are possible. Further information is expected.

slept over 20 hours day 4, plus 12 day 5; Joint and muscle pain; Joint and muscle pain; extreme fatigue/exhausted; Congested with runny nose; Congested with runny nose; itchy eyes; generally feeling ill; This is a spontaneous report from a contactable other healthcare professional reported for herself. A 40-year-old female patient (patient was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3247, Expiry date: unknown) intramuscular, administered in Arm Left on 29Jan2021 09:45 am (at the age of 40-years-old) at a single dose for covid-19 immunisation. Medical history included sinus tachycardia, panic disorder, depression, chronic fatigue syndrome, PCOS. Allergies to medications, food, or other products was Penicillin. Concomitant medication patient received within 2 weeks of vaccination included Metformin 500mg, Metoprolol 50 mg, Paroxetine 50 mg and vitamin D. The patient previously took first dose of BNT162B2 (lot number: EL0140) on 08Jan2021 on right arm at a single dose for covid-19 immunisation and 2 weeks or so after first shot, noticed severe itching on my left upper thigh with bumps and after this shot, itching has spread to face and arms. The patient experienced joint and muscle pain, extreme fatigue/exhausted on 31Jan2021, slept over 20 hours day 4, plus 12 day 5 on 01Feb2021 and congested with runny nose, itchy eyes, generally feeling ill in 2021. The event was considered as non-serious. Facility where the most recent COVID-19 vaccine was administered was Nursing Home/Senior Living Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. No treatment was received for the adverse event. The patient underwent lab tests and procedures which included Oropharyngeal: negative on 01Feb2021. The outcome of all the events was not recovered.

Fatigue on-going. Retinal/occular migraine - left eye sight blurry, flashing, spinning zig zag lights without bad headache. Never experienced the vision issue before.

Red raised areas that start at left eyebrow and go into hairline. Red raised bumps throughout scalp on the left side. Left swollen lymph node behind ear that is continuing to swell. Pressure from lymph node swelling now felt near left eye. All bumps can be itchy at times.

Adverse effects were Covid-19 like symptoms that consisted of; foggy brain, extreme thirst, chills, shakes, cold, fever, body aches, loss of taste and extreme exhaustion.

Within minutes of receiving the injection I experienced waves of dizziness to the point of almost passing out, rapid heartbeat, full body hot flashes, sweating, hand tremors,, dry mouth Observed for 30 min and released with no intervention. Waves of vertigo continued throughout the day, but are decreasing in frequency but not intensity as days go on. Within an hour of injection psoriasis on left leg flared and was raised, red and extremely itchy through Sunday, 4.11.21. Severe headache through end of day on 4.9.21. Treated allergic symptoms with 10ml Benadryl every 5 hours for 2 days, Ibuprofen PRN for pain. All symptoms subsided except for headache and dizziness/vertigo but appears to be decreasing in frequency but not intensity.

had swelling of cheeks, lips, cough , trouble swallowing about 30 minutes after vaccine administration

Flushed face and chest pressure at 09:34. Patient brought her own childrens oral Benadryl and took 40 mL as instructed by her doctor . At )9:53, patient stated her throat was getting tight and her tongue swelling so she received a epipen.

Rash on entire body mainly torso. Extra sensitive gums that bled when teeth were brushed. Rash on inside of both lips and in the back of my throat. Diarrhea, body aches, vomiting, mild fever, splotchy skin,

Patient developed temporal headache 5 minutes post vaccination, along with slight dizziness, dry mouth, and inability to catch a deep breath. Patient laid down to rest, had vitals checked. Patient was moved to a sitting position after 10 minutes, and stated that she felt better. She was given some water and monitored for another 10 minutes. Vital signs were rechecked and she was released.

Have developed large red welt at injection that has been spreading slowly and continuously over past 30 hours. Started approximately size of dime, is larger than a quarter after 30 hours. Red in color, hot, swollen. Left ear is starting to get swollen and painful on inside - due to swollen lymph node under ear.

Headache & Numbness in lips/nose within the 1st hour. I called to report symptoms and was advised to monitor and if gets worse to call back and go to ER. At this time I am ok and no need to go to ER as I am not having trouble breathing and no swelling.

I started to feel a tingling sensation on my tongue about 2 hours after the injection. It did not get worse and has remained constant. I fell asleep and woke up with the sensation of my tongue tingling. It has been almost 24 hours since the injection and it still tingles.

Severe leg pain (inability to stand for longer than a minute). Extreme fatigue. Facial numbness. Loss of taste.

I have been experiencing these symptoms for three days now. -moderate dizzy spells/vertigo -severe headache -severe fatigue -sore arm in injection site -swollen lymph nodes -tingling in tongue -achy muscles/joints

Less than 24hrs after first shot on 03/24/2021 right ear is muffled. Feels like it clogged. Never went away Less than 24hrs after second shot on 04/14/2021 right ear is still muffled and now I have a buzzing sound in my ear.

Tunnel vision, near syncope, rapid heartbeat, rapid increase in blood pressure. Lasted at least 30 minutes while I waited at the clinic. Was given one Benadryl. Symptoms cleared but was still not symptom free when I drove home.

My left eye started twitching within two days of getting the first dose. This persisted and accelerated after the second dose. While it has mostly subsided, the twitching does occasionally return.

Burning in chest and throat. And weird taste along with it. As if after getting and iodine shot for a cat scan.. the same metallic taste.

Seconds after injection my left arm had an icy numb sensation from injection site to my fingers. Today Three weeks later I experienced same icy sensation plus numbness/weakness, decreased sensation in fingertips. 2. Still have bad Headaches still after 3 weeks 3. Extreme Fatigue still after 3 weeks 4. Last few days, three weeks after shot, I have worsening/ Increased joint pain, spiky pain in joints, chills and entire body aches like I have the flu. No fever, no runny nose, etc. Just the body aches, joint pain like people experience with the flu. 5. Decreased mental sharpest last 2 weeks since shot. 6. Light headedness, dizziness. 7. Immediately after shot I experienced metal taste in my mouth. Since the shot, I still experience occurrences of metal taste every day. 8. Today experiencing slight numbness in right foot. 9. Swelling in fingers

Site: Pain at Injection Site-Medium, Systemic: Visual Changes/Disturbances-Severe, Additional Details: Pt said her arm was sore for two days and also her Left Eye Burned and felt like acid was in her eye for about 90 second time periods about 3 episodes a day for 2 days.

Body aches, chills, fatigue, headache, and eye pain for 24 hours. Arm soreness at the site for 3 days, followed by swelling and itch on entire upper arm where vaccinated. Swelling and itch lasted for 10 days.

I woke up with a swollen and itchy upper and lower lip. Also, the area under the tongue is swollen and sore. I have not used a different product or eaten any different foods. I am taken Benadryl and it seems to be helping.

Asymptomatic until bedtime, 101.9 fever for 6 hours and currently 100.3, but it's fluctuating. Severe shaking chills, and throbbing bone and joint pain. My perineum also oddly feels as though I've been kicked rather hard. Sleepless night until chills subsided. Then experienced mild nausea, and pain in both palms while hand washing. No congestion, but dry inflamed sinuses and eye pain. I developed a headache this morning, but only while standing.

Children said I would sit up say weird things then faint; dizzy; heavy eyes; heavy head; laid down do not remember anything from the evening; Children said I would sit up say weird things then faint; severe vertigo; confusion; shook uncontrollably for 30 minutes; This is a spontaneous report from a contactable consumer(patient). A 40-year-old non-pregnant female patient received first dose of BNT162B2 (FIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at 10 am (Batch/Lot Number: EN 6199) as single dose (at 40-year-old) in arm left for COVID-19 immunization. The patient wasn't pregnant at the time of vaccination. The patient had ongoing allergy to intravenous pethidine hydrochloride (DEMEROL). No other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included amfetamine aspartate/ amfetamine sulfate/ dexamfetamine saccharate/ dexamfetamine sulfate (ADDERALL). Prior to vaccination, it's unknown if the patient was diagnosed with COVID 19. Since the vaccination, the patient hasn't been tested for COVID19. At 7pm the patient became incredibly dizzy, heavy eyes, heavy head, laid down did not remember anything from the evening. Children said she would sit up said weird things then faint. Laughed and shook uncontrollably for 30 minutes. Next morning severe vertigo, confusion. Went away the third day. No seriousness criteria reported. The events resulted in doctor or other healthcare professional office/clinic visit. Treatment received for the events. The outcomes of the events were resolving.

Metallic Taste in Mouth; Sweating; Vertigo; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 40-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Brand: Pfizer), dose 1 via an unspecified route of administration in Arm Left on 29Mar2021 16:30 (Lot number and expiry date was not reported) as single dose for covid-19 immunisation. Medical history included hypersensitivity from an unknown date and unknown if ongoing Allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. Prior to vaccination, was the patient diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 29Mar2021 16:45, the patient experienced metallic taste in mouth, sweating and vertigo. Therapeutic measures were not taken as a result of adverse event. The outcome of the event was recovered on an unspecified date in 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained

10 MINS AFTER VACCINE, FELT ITCHY THROAT AND TOP OF MOUTH. WATER GIVEN IN OBS, IMPROVED AFTER A FEW MINUTES, STATES JUST FEELS LIKE MILD ALLERGY TICKLE/IRRITATION IS ALL THAT REMAINS. INSTRUCTED ON BENADRYL IF NEEDED AT HOME AND TO MONITOR AND SEEK FURTHER EVAL IF WORSENS. ESCORTED TO EXIT TO MEET SPOUSE WITHOUT ISSUES AT 1545. 1530 INITIAL BP 172/97 HR 98 RR 20 SATS 98% ON RA (REPORTS SITUATIONAL ANXIETY) 1540 BP 131/88 HR 73 RR 18 SATS 100% ON RA

Extreme head ache, irritability, dry mouth, numbness and tingling of my left arm, my tongue feels tingly. I feel like I drank about ten red bulls my heart feels like its racing!

- Sudden loss of hearing in left ear on April 10 (5 days after second COVID shot) upon waking up in the morning around 8:00 am. - Loss of hearing was becoming more pronounced, so I went to the doctor for an exam on 4/14. Dr. could not determine cause of hearing loss. Scheduled an audiology exam and appointment with ENT for 4/15. Doctor prescribed oral steriods to try and save hearing. While I was at the pharmacy waiting for my Rx, I suddenly developed vertigo around 5:30 pm, which resulted in being sent to the ER. I could not stand, felt faint, and was vomiting excessively. - At the ER, was given lots of anti-nausea medication. Eventually, the tests determined that there was nothing obviously wrong in my brain (aneurysm, stroke, tumor, etc.), and the medication stopped the vomiting such that I was able to be discharged around midnight.

Approximately 3 to 4 minutes after receiving my first vaccine, I had a hot feeling travel from my toes up to my head. I then became dizzy and felt very faint. The tip of my tongue also became numb. I was too embarrassed to alert the hospital worker. The sensation lasted about a minute. However, the last 2 1/2 days I have been having a fast heart rate after doing minimal activities. I feel very winded by the slightest task. I did go to a clinic today to get my vitals checked. They were fine- but I still continue to feel like my heart rate spikes when I do something as minimal as emptying the dishwasher. It?s very scary and uncomfortable and makes me fearful of taking the second shot.

Approximately 50 minutes after injection, having waited the 30 minutes for observation, while driving home my tongue started to feel wrong and the top started to tingle. Uncertain which direction this was going to go, I drove to the ER (which was near home, close to where I was at the time). I felt light-headed for a little bit just after getting a room and talking with the insurance & copay person. The doctor noticed I was flushed/red, which extended from my face down my chest and shoulders. The reaction didn't seem to progress further than that, thankfully. I was treated with Solumedrol, Famotidine, Benadryl.

I received my first dose of the Pfizer vaccine on April 7th. The same day that I received it my eyes turned red, blood shot. Specifically the left eye, and I had my shot in the left arm. I thought it was odd but after a day or so it went away. On 4/17 I went to the beach, and my eyes got almost sun burnt even while wearing sun glasses with a hat, under an umbrella. I go to the beach all the time and this has never happened before. I do not know if any of this is related to the vaccine and my symptoms are not drastic enough to warrant a trip to the doctor yet, however I felt that I should report this.

Oral swelling, hot flashes. Patient did not seek medical attention during event, states she self medicated with diphenhydramine within an hour of vaccination. Symptoms completely resolved by next morning. Patient endorsed symptoms during screening for second dose of vaccine 21-days later.

Patient received first dose of COVID vaccine today, appointment time 1430, received first dose vaccine at 1433. After receiving vaccine, patient sat in observation area and reported her voice "going away" sharing that with other allergies her voice often softens and she has a hard time communicating. No signs of shortness of breath, respirations even and not labored, oxygen sat at 100%, pulse 102, BP 112/66. Face flushed. Administered 1ml of benadryl IM, 50 mg total. Patient still expressing difficulties verbalizing and now stating a small feeling of tightness in her throat, face continued to be flushed. Administered epi pen to left thigh. Called 911. BP 110/60, 109, 100%. Gave report to ED RN and to paramedic responding. Patient then transferred to ED with paramedic assist. At time of transfer, patient reporting improvement with ability to communicate via voice, face less flushed and improved tightness in her throat.

throat constriction, dryness, scratcy/itchy. facial itiching, head, arm, back itching, eye swelling, overheating, tachycardic. epinephrine administered, 911 called, ambulance taken across the street to ER for observation. steroids given. further benadryl taken at home. symptoms started 10-15 minutes post injection. I am allergic to PEG, my allergist put me on a pre dose of anthystamines & steroids to lessen or prevent reaction so overall reaction was fairly mild but epi was the only thing left to give as I had already had 400mg hydroxyzine, 40 mg pepcid x3, 28mg medrol x5 during the 24 hours prior to my vaccination.

Several days after 2nd dose of Pfizer I started experience increased pain in my jaw as well as my right thumb. I do have TMJ though it is controlled/mild and haven?t had issues with it in a few years. After 2nd dose experience pain and discomfort throughout the day. I have also been experiencing increased pain and discomfort in my right thumb where I believe I have some signs of arthritis since receiving the 2nd dose.

-LIMP ARM WITHIN 30 MINUTES OF VACCINATION -LEFT ARM, NECK, AND FACE SWELLING WITHING AN HOUR OF RECEIVING VACCINE - LASTED FOR 6 DAYS -UNABLE TO MOVE LEFT ARM, RAISE IT, OR LIFT ANYTHING FOR THE PAST 18 DAYS -UNABLE TO GRASP OBJECTS WITH LEFT ARM FOR THE PAST 18 DAYS -UNABLE TO SLEEP ON LEFT SIDE - CAUSES EXTREME PAIN -TINGLING AND NERVE SHOOTING PAIN ON LEFT ARM FROM FINGERS TO NECK, FRONT AND BACK CHEST LEFT SIDE -MUSCULAR NODULE DEVELOPED ON LEFT SHOULDER UP TO MY KNECK - CAUSING SEVERE EAR PAIN -EXTREME FATIGUE - LETHARGIC FOR THE PAST 18 DAYS -SEVERE JOINT/PAINT THROUGH OUT ENTIRE BODY -LOST OF TASTE -NIGHTSWEATS FOR PAST 18 DAYS -FEVERS RANGING BETWEEN 99.0 - 103 F FOR PAST 18 DAYS -NAUSE FOR PAST 18 DAYS -LOST OF APPETITE -DIARRHEA AND LOOSE STOOLS FOR THE PAST 8 DAYS (NO BLOOD) -BRAIN FEELS FOGGY ALL THE TIME - FEELING AS IN A DAZE FOR PAST 18 DAYS -SHORTNESS OF BREATH - JUST FROM WALKING OR MOVING AROUND -SKIN IS SUPER SENSITIVE AND ITCHY -UNABLE TO DRIVE BECAUSE OF THE FATIGUE AND UNABLE TO USE LEFT ARM. -UNABLE TO WORK - RELYING ON OTHERS TO TAKE CARE OF ME.

Tinnitus. I had a very mild case prior to last week due to side effects of migraine medications in the past; unless in absolute silence, I usually forgot I had it. The volume has increased by at least 3 or 4 times; it is now shrill and ever-present.

Patient (DOB 6/11/1980) received dose 1 of the Pfizer COVID vaccine (lot EW0162, expiration 7/2021) at 1050. At 1052, patient laid down on the ground with her feet propped up on her chair in the observation area. PHN and RN approached the patient to assess. Patient reported blurry vision and feeling as though she was going to faint before she laid down. Patient reported a fear of needles and fainting with previous injections. Vital signs: O2 98%, pulse 72, blood pressure 120/90, respirations 14. Patient reported eating breakfast then going on a run before coming to the vaccine POD. Patient denied allergies, medications, or medical conditions. At 1058, patient reported symptoms were improving. Vital signs: O2 97%, pulse 70, blood pressure 120/95, respirations 14. At 1102, the patient sat up, drank some water, stated she felt wobbly and laid back down. Vital signs at 1104: O2 98%, pulse 66, blood pressure 120/90, respirations 14. Patient sat up reporting decreased dizziness. At 1114, vital signs: respirations 16, O2 99%, pulse 72, blood pressure 120/98. At 1116, patient stood up momentarily while monitored closely by PHN and RN, then laid down again reporting feeling dizzy. Vital signs at 1118, O2 96%, pulse 69, respirations 16, blood pressure 120/90. Patient sat up, then laid down again reporting dizziness. PHN asked patient to contact a family member to drive her home. Patient reported she wanted to leave and wait for her husband in her car instead of the vaccination room. PHN encouraged patient to wait in the observation room so medical staff could monitor until symptoms resolved or called 911 per emergency protocol. At 1130 patient sat up. At 1138, patient stood up, denied dizziness. RN walked patient out to the parking lot. Patient left at 1140, walking with steady gait.

Received 2nd COVID vaccine on 1/9/2021. On 4/11/2021 developed headache, loss of taste/smell, and nasal congestion. Tested positive for COVID.

The day of and day after my arm was sore at the injection site and hard to lift. I also had a headache. Both went away after 2 days. However, 9, days later I noticed red spots on my thighs that were itchy. As the day progressed they got worse and bigger and itchy. They were red raised lesions. I woke up in pain and noticed the spots all over my thighs; buttox and my lower lip became very swollen. I went to the hospital they said it was an allergic reaction to something. I had not done anything out of the ordinary in the last couple weeks other than the 2nd dose of the vaccine and a spray tan. They gave me Benadryl and steroids

Upper respiratory congestion, mild nonproductive cough. Dizziness. Headache. Eye pressure. Diffuse body aches: "Heaviness" in legs; not weakness. Mild nausea associated with coughing, however no emesis. Denies chest pain/abdominal pain. albuterol 90 mcg/actuation inhaler 6 puff 6 puff, Inhalation, Once, Fri 2/5/21 at 1610, For 1 dose guaiFENesin ER 12 hr tablet 600 mg azithromycin tablet 500 mg D/c with new Rx for: Azithromycin 250mg: 2tabs PO on day 1, then 1tab on days 2-5 Mucinex 600mg 12 HR tablet: 1 tablet PO BID x7 days Encounter Diagnoses 1. Suspected COVID-19 virus infection 2. Upper respiratory tract infection, unspecified type

Symptoms started approximately 23 hours after my first Pfizer dose. I had a visual disturbance that lasted ten minutes. First my vision went blurry at the edges, then I saw flashes of light and eventually I saw a zigzag pattern across my vision. Since this happened the left side of my face primarily above and below my eye has been tingly and numb feeling, as well as slightly swollen. I have also had vertigo for 11 days now that is getting worse instead of better.

swelling of lip; This is a spontaneous report from a contactable physician (patient). A 40-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in arm right on 26Jan2021 10:00 (Batch: EJ1685; Lot Number: EL3248; expiry: not reported) as single dose for covid-19 immunisation at hospital (at the age of 40 years). Medical history was none. The patient concomitant medications were not reported. No predisposing factor and no culture performed and no antipyretic use (around the date of Vaccination). On 26Jan2021 10:00, the patient experienced swelling of lip occurred after second dose. The patient also stated that the no action was taken for adverse event (no therapeutic measures were done) and reaction recurred on re-administration of product. The outcome of event was unknown. Pfizer product had a causal effect to the adverse event (Causal Relationship): Yes

Pt endorsed a swollen tongue several minutes after receiving the vaccine. Pt was given Benadryl IM and released.

blurred vision in both eyes which lasted for 30 minutes. at 30 minutes the vision was back to 90% and returned to 100% soon after.

Within 15 minutes after receiving the first vaccine shot I was I was lightheaded and had a metallic taste in my mouth. The metallic taste went away but I felt light headed until I fell asleep. At 2:00am woke up with severe muscle aches all over my body. The next morning I woke up sweating, muscle aches, lightheaded, fatigue, and nauseated. I also had a headache but it was a different type of headache than I?ve ever had before, it felt like my eyes were going to pop so I decided to check my heart rate and blood pressure and both were high. My blood pressure was 132/89, it is typically low (around 104/55). My heart rate was 109 and it?s typically in the 60?s or 70?s. I stayed with these symptoms until 04/17/2021. On 04/18/2021 I woke up for the first time since receiving the Covid-19 vaccine not sweating, hurting, and with a normal heart rate and blood pressure. As of today 04/25/2021 I am still dealing with fatigue.

From 10pm on Monday 5 April until the morning of Wednesday 7 April (approximately 33 hours) I had a severe reaction to the second dose of the vaccine. The night of 5 April I had extreme chills, uncontrollable teeth chattering, and freezing sweats. I had sharp shooting pains in my feet, legs, hands, and arms that lasted 24 hours. I also had sharp shooting pains in the back of my head and then it began in my ears. When moving my head for the next full day I experienced extremely sharp pain in one or the other ear. Sometimes the pain returned in my arms. I had tightness in my chest, shallow breathing, and extreme fatigue but also could not sleep due to the pains and the sharp ear pains when turning my head. I had a fever from 100-101 degrees from the first night and still had 101 at 10pm on 6 April (24 hours later). That night I took a Motrin due to the sharp ear pains. (The first night I had only taken Tylenol.) Throughout the second night, I woke up many times drenched in sweat and upon waking up on the following morning, my fever had broken. Throughout day 3 (Wednesday 6 April), I still had tightness in my chest, shallow breathing, and periodic sharp ear pain when moving my head but my fatigue, chills, and fever had subsided.

anaphylaxis; rash/hives on face; rash/hives on face; progressed to swollen lips, tongue; progressed to swollen lips, tongue; cough; throat irritation; wheezing; This is a spontaneous report from a contactable consumer (patient). The 40-year-old non pregnant female patient received first dose of BNT162B2 (Pfizer Covid-19 vaccine, lot number: EW0150 expiry date unknown) via an unspecified route of administration on Left arm as a single dose on 06Apr2021 09:30 AM. Medical history included asthma, known allergies: Biaxin, albuterol, xopenex, apples, pears, stone fruit (peaches, plums, apricot, etc), almond, hazel-nut. Concomitant medications included Zyrtec, Nasonex, Flovent, Singulair and Zoloft. On 06Apr2021 10:00 AM, started with rash/hives on face, then progressed to swollen lips, tongue, cough, throat irritation/swelling and wheezing. Initially treated in emergency room (ER) for anaphylaxis then released. Within 30 minutes, symptoms returned and was treated ER for anaphylaxis and was admitted for observation. She was discharged in the morning of 07Apr2021, but had to return to ER that evening, and was discharged in the morning of 09Apr2021. She was treated with Epinephrine, Benadryl, steroids and Pepcid. She did not receive any other vaccine in four weeks prior to the suspect. The patient was not suffering from covid prior vaccination. On 06Apr2021, she was tested through Nasal Swab for Covid and results were found to be negative. The outcome of events was recovering. No further information was available.

Patient stated she took the vaccine on Monday 4/5/21 @1600 and within 10 minutes she felt her arm started to go numb and it was swollen (face and neck), radiating back pain and a nodule in neck and pain shooting all throughout the arm, loss of appetite, n/v, sob (no chest pain), lethargic, fever (ranging from 99-103), diarrhea developed within the last week, lost a sense of taste, headache, she can move arm but she's in a lot of pain.As of 4/22/21 patient is just experiencing shooting arm pain, nausea, fever, lethargic, SOB (patient feels exhausted when moving around the house), and started to experience some itchyness as of this morning. Patient took tylenol at least 6 times since she took the vaccine, she stated it helps with the pain but once it wears off the pain comes back. Advised patient to continue with the tylenol/ibuprofen for the fever and pain, and benadryl to help with itchiness or she can apply benadryl cream/hydrocortisone to help. Also advised her that if her sob continues and it gets worse to seek medical attention (ER or urgent care). 4/25-Patient continues with fever, negative for Covid test, continues with loss of taste, recommended for her to see primary provider.

weird feeling, itchy all over mostly arms. increased phelgm with throat / tongue/ swelling; anxious.

Received the vaccine at 9:30 am. Originally felt fine with mild soreness in the arm. Woke up around 2:15 am to use the restroom, and got extremely dizzy... started to feel weird, and felt like there was a rush all over. My head started to feel like it was closing in and there was a static, crackling, speaker-like sound along with tinnitus in my ears making it feel like I was in a tunnel. I sat on the floor and waited several minutes until the feeling passed and was able to get back into bed. I waited several more minutes until I felt "normal" again. Was able to get back to sleep, and feel better this morning, with no dizziness, but will continue to monitor any additional symptoms closely.

Possible TIA (diagnosed in Urgent Care); loss of balance; dizziness; headaches; neck pain; blurred vision/blurry eye (right); right arm/leg weakness; This is a spontaneous report from a contactable consumer (the patient). A 40-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown due to it was never shown vial, just administered injection by nurse) via an unspecified route of administration in left arm on 16Apr2021 18:00 at age of 40-year-old at single dose for COVID-19 immunisation. Relevant medical history was "none". No known allergies. Concomitant medications included levocabastine hydrochloride (ZYRTEC) taken for an unspecified indication from an unspecified date, and multivitamin. The patient did not take other vaccine in four weeks. No COVID prior vaccination. COVID not tested post vaccination. The patient experienced Possible TIA (diagnosed in Urgent Care), loss of balance, dizziness, headaches, neck pain, blurred vision, right arm/leg weakness, blurry eye (right). The events onset date was provided as "18Apr2021 10:00 a.m.". The events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). No treatment received for the events. The outcome of the events was not recovered. Information about lot/batch number has been requested.

Wed, April 14: headache, light headed, feeling of going to pass out, blurred vision, very tired, weak, diarrhea. Thur April 15 ? very light headed, feeling of going to pass out, numb pinky, very weak, very shaky, very tired. Went to ER after almost passing out they gave me fluids, did a chest xray and ekg, covid test, pregnancy test. They sent me home saying I was dehydrated. ? slept for 4 hours after ER, felt tired, hard to focus, diarrhea then that night slept all night. Fri April 16 ? a bit better in morning but vision still not right, at dinner table felt drunk (did not have any alcohol), very tired, face felt flushed (no fever), hard to focus, headache came on before bed (took 2 Aleve) Sat April 17 ? tired, went to doctor for additional blood work, slept after appointment, face flush (no fever), vision still not right. Doctor said this is likely vaccine related. Sun April 18 ? felt same as Saturday Mon April 19 ? very tired, vision still not right, hard to focus at work, want to sleep, face felt hot and tingly (no fever) Tue April 20 ? allergy type symptoms in morning. Sneezing, runny nose, slight headache. These symptoms went away. From April 21-28 - other symptoms mostly going away except vision issues. April 28th most symptoms went away but vision is still blurry, see floaters, feels like I have Vaseline over my eyes. Going to see an eye doctor ASAP.

Exhaustion and nausea for 2 days. The same time jaw tightness ear pain, ringing and fullness started. These other symptoms are still present after almost 3 weeks.

15 minutes after receiving the vaccine, she experienced numbness in her lips (felt 'swollen'). She sat 15 minutes and felt it spread. She talked to the medic, it was still present 30 minutes later. She was noted to have high blood pressure (maybe systolic BP 160-180 mm Hg with elevated HR, does not recall specifics). She was sent to the ED. The numbness over that period spread to the arm and down both legs. She had loss of dexterity in hands (could not peal the aluminum top off an orange juice cup). Mild proximal arm weakness. She was not able to walk. She was numb all over but the right was more affected. She was seen in ED that day 09MAR and later admitted. Later that night had some throat closing/gasping for air sensation. She was monitored clinically, worked with physical and occupational therapy. We chose not to perform a diagnostic LP and just monitored clinically. Work-up detailed below. Discharged hospital on 12MAR. She gradually recovered over several weeks. She was even able to get second dose in series on 3/30/2021 (Pfizer-BioNTech Covid-19 vaccine, lot #: ER 8133, exp 7/2021). She was almost 100% about 3 weeks later. She had a similar return of the numbness and it was in her throat as well, but was immediately controlled by taking diphenhydramine OTC. She was 100% back to normal at our follow-up on 4/27/2021.

1/28 1st Pfizer > 1/29 Onset, dizziness, nausea, h/a, eye pressure, "heaviness" in legs, altered taste 2/3 Cough, mild congestion Seen in ER on 2/5 for evaluation of cough. Reports 3 days of upper respiratory congestion, mild nonproductive cough. Diffuse body aches. Mild nausea associated with coughing, however no emesis. Denies chest pain/abdominal pain. ROS positive for: fatigue, congestion, cough, myalgias.

The evening of the vaccine I started getting sore ovaries, which continued for about 3 days, waking me up that first night with the pain. It felt like they were hot and aching, like they were working very hard, something I haven't experienced before. This was 5 days after my last period finished. I had spotting the next day, which I never have, and then my breasts became very sore, lumpy and tender for the next week or more - very concerning as I have had a fibroadenoma before. Symptoms were similar to being pregnant, but I have just started my next period, and did a pregnancy test which came back negative. I have also had ongoing light tinnitus, which started a few days after the vaccine. Again, I haven't had this before, and it has been almost 3 weeks now and it is still at the same intensity. I am very worried about getting the second vaccine next week.

Headache with blurred vision, nerve burning pain throughout my body, muscles cramping and pain in both legs and ringing in both ears. Tinnitus. And I've did not have this before my vaccination.

Experienced lip swelling, redness, and tingling; tingling, itchy, and slightly swollen tongue; itchy throat; and fast heart beat. Symptoms began approximately 15 minutes after I received the vaccine. I was 4.5 months pregnant at the time, due date September 5, 2021.

Severe flu like symptoms. Body hurts to even touch from head to toes, uncontrollable shaking/shivering, freezing hold or suffocating hot, eyeballs keep loosing focus, feeling like I'm having a anxiety or panic attack, short of breath. First day I felt fine, next day I woke up feeling like I was hit by a car and second day after I'm feeling all the symptoms listed above on a scale of 1-10 I'm at a 10 for discomfort

then itch was mild for 1 hour/Started itching all over the worst was behind; itching all over the worst was behind my eyes deep in sockets; Sharp pain both arms 1 min.; left arm was swollen; This is a spontaneous report from a contactable consumer (patient). A 40-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 30Apr2021 at 11:15 (at the age of 40-years-old) as 1st dose, single for COVID-19 immunisation. Medical history was reported as yes but not specified. The patient's concomitant medications were not reported. On 30Apr2021 at 11:15, the patient experienced sharp pain both arms for 1 minute then itch was mild for 1 hour. Started itching all over the worst was behind her eyes deep in sockets that lasted 2 days, had to take diphenhydramine (BENADRYL). Left arm was swollen that night and lasted 2 days. On day 3, she was still itching but not as bad. Therapeutic measures were taken as a result of all events. The outcome of the events was recovering. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.

broke out in canker sores all over mouth again; Slept 17 hours q day; severe fatigue; Sinus and ear pressure; Sinus and ear pressure; Generalized aching; break out in canker sores all over my mouth; sore muscles all over; joint pain; mild itching to upper torso, breasts and under arms; low grade fever; chills; face became pink and warm; felt burning sensation throughout my body; This is a spontaneous report from a contactable nurse (patient). A 41-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in deltoid left on 03Feb2021 12:00 (Batch/Lot number was not reported) as 1st dose, single at age of 40-years-old for covid-19 immunization. Medical history included Asthma, 3 herniated discs in neck, hx of pneumonia, hypertension (HTN). Known allergies included: Ceclor, PCN, Doxycycline, Bactrim DS, Codiene, berries and anaphylaxis to Latex. Concomitant medications the patient received within 2 weeks of vaccination included: lisinopril; hydrocodone bitartrate, paracetamol (HYDROCODONE/ACETAMINOPHEN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Adverse event started on 03Feb2021 14:00 PM, within first 24 hours the patient experienced mild itching to upper torso, breasts and under arms, also had low grade fever and chills in this time. Within first 24 hours, face became pink and warm, and felt burning sensation throughout her body. At this point the patient took Pepcid and Benedryl and it seemed to control symptoms. On 09Feb2021, the patient begun to break out in canker sores all over her mouth, total of 5 (the patient did not have a canker sore since high school), began to develop sore muscles all over and joint pain that progressed to severe by 12Feb2021. Worse in mornings. Got a flu and covid test (Nasal Swab). They were negative. 17Feb-20Feb2021 severe fatigue and cont. Joint pain. Slept 17 hours q day. Sinus and ear pressure. Generalized aching. The patient did not get 2nd vaccine. 01Mar2021 broke out in canker sores all over mouth again. Took 4 days to resolve. The patient was still having significant joint pain throughout her body, worse in mornings. The patient never had this before vaccine. Events resulted in disability or permanent damage. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the event canker sores was recovered, of other events was not recovered. Follow up needed, further information has been requested.; Sender's Comments: "Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded" The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

About 20 minute after vaccine was administered I felt a subtle numbness feeling to the right of my mouth. Then it was felt on most of my right cheek. It lasted the whole day and the next morning it was mostly gone. Since then my right eyelid and under eye have been a little red which isn't normal for me. Some tingling in right leg felt as well. Mainly concerned about the face sensation and not sure if I should proceed with second shot.

My tongue became swollen and my mouth became dry. I began chewing on the inside of my cheeks and my teeth left groves on the perimeter of my tongue. The swelling lasted around 2 months and I am still experiencing extremely dry mouth and issues swallowing, especially at night. Initially my Dr prescribed an oral rinse for non-typical thrush, but it didn't really help. I saw an ETN who told me to take a multi vitamin. Both Dr's ran blood work.

Slight tinnitus that comes and goes in both ears. More concerning is intermittent hearing loss in right ear. Feels like hearing volume turns up and down, as though there is a blockage. There is also pressure that won?t go away (pop). I have not sought treatment and am waiting to see if issue resolves on its own. I don?t want to take steroids.

left side of lower lip swelled up.; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route of administration in the left arm on 23Feb2021 at 09:30 and received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route of administration in the left arm at 09:15 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medication were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not have any allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 17Mar2021, the patient's left side of lower lip swelled up, about 18 hours after the second dose. The patient had no trouble in breathing. The patient did not receive any treatment for the event. The clinical outcome of the event left side of lower lip swelled up was recovered on an unspecified date. Information about lot/batch number cannot be obtained. No further information is expected.

Left arm numbness; hand tingling; left jaw pain; Left side of face and scalp began to burn; Internal tremor of the brain; dizziness; This is a spontaneous report from a contactable consumer reported for herself. A 40-years-old non-pregnant female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE,: solution for injection, Batch/Lot Number: Er8730 and Expiration date was not reported), via an unspecified route of administration, in right arm (age at vaccination 40-year-old) as 2nd dose, single for covid-19 immunisation and patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE,: solution for injection, Batch/Lot Number: En6208 and Expiration date was not reported), via an unspecified route of administration, administered in right arm on 19Mar2021 09:45 AM for covid-19 immunisation. Medical history included hypervitaminosis, migraines, and prior to vaccination, patient was diagnosed with COVID-19. The patient was allergic to Levaquin. Concomitant medications that patient received within 2 weeks of vaccination included ferrous citrate (IRON [FERROUS CITRATE]). Facility where the most recent COVID-19 vaccine was administered in hospital. Patient did not receive any other vaccines within 4 weeks previous to the COVID vaccine. Prior to vaccination, patient became now not diagnosed with COVID-19. Patient underwent laboratory test which includes nasal Swab Pcr, covid test on 11May2021 and the result was pending. On 09Apr2021 10:00 the patient experienced left arm numbness 5 minutes after injection, hand tingling, left jaw pain. Left side of face and scalp began to burn one day after injection. Internal tremor of the brain and dizziness. Treatment was received for all event as medical supervision from hospital staff. Since the vaccination, the patient was not tested for COVID-19. The outcome of events was not recovered. No follow-up attempts are needed. No further information is expected.

TINNITUS bilateral, loud, persistent Joint soreness Foggy thinking Pain at injection site Headache Weird twinges all over body randomly

Patient stated prior to vaccine that she had itching and throat tightness after her first Pfizer vaccine from Pharmacy. It was resolved by PO Benadryl. Patient took 25 mg Benadryl PO prior to receiving 2nd Pfizer vaccine. After vaccine, patient reported throat tightness, mouth tingling, and shortness of breath. Epipen 0.3mg SubQ was administered. Patient taken to ER. Given methylprednisolone 125mg x 1 before discharge from ED with prednisone prescription.

I became very light headed and passed completely out. I do not remember anything leading up to this or while it was happening. When I came too, I couldn't hear, had ringing in my ears, couldn't walk on my own, and my husband said I was very cold. Two days later and i still have dizzy spells and extreme fatigue.

Heart pounding and fluttering; Migraine headache; neck pain; dizziness; head and neck hot to the touch (no fever); eye pain; exhaustion; vertigo; mild nausea; Left temple throbbing and pulsating/headache; Heart pounding; This is a spontaneous report from a contactable consumer (patient). A 40-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 30Apr2021 16:30 (Batch/Lot Number: ER8736), age at vaccination of 40-years-old, as single dose, for covid-19 immunisation. The patient medical history was not reported. The patient was not pregnant and was not pregnant at the time of vaccination. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced migraine headache everyday, neck pain, dizziness, head and neck hot to the touch (no fever), eye pain, exhaustion, some vertigo and mild nausea, left temple throbbing and pulsating, heart pounding an fluttering occasionally, all on 30Apr2021 at 1730. No treatments were give for the events. Facility where the most recent COVID-19 vaccine was administered: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient underwent lab tests and procedures which included sars-cov-2 test negative on 10May2021. The patient had not recovered from the events. Information on the lot/batch number has been requested.

Metallic taste in mouth; Chills/hot spells; nausea; vomiting; body aches; hip and back pain; sharp pain in left upper chest; Chills/hot spells; This is a spontaneous report received from a non-contactable Other-HCP. A 40-Year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EN9581 and Expiration date not reported) via an unspecified route of administration, in Arm right, on 13Feb2021 at 02:30 PM (at the age of 40 years) as 2nd dose, single for COVID-19 immunisation. The patient medical history included Known allergies was reported as pseudoephedrine, Cephalexin, eggs, melon and concomitant medications included Multivitamin, St Johns Wort (medications in two weeks). Historical vaccine includes BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EL3246 and Expiration date not reported) via an unspecified route of administration, in Right arm, on 23Jan2021 at 02:30 PM as 1st dose, single for covid-19 immunisation. The patient didn't receive any other vaccine in four weeks. There was no covid prior vaccination. The patient was covid tested post vaccination. On 13Feb2021, at 02:45 PM, the patient had experienced Metallic taste in mouth and feeling hot initially, Chills/hot spells, nausea, vomiting, body aches, hip and back pain, sharp pain in left upper chest. Adverse event resulted in Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests which includes Rapid Antigen Nasal Swab test post vaccination on 15Feb2021 with the result of negative, on 17Feb2021 with the result of negative, on 19Feb2021 with the result of negative, on 22Feb2021 with the result of negative, PCR Nasal Swab test on 24Feb2021 with the result of pending. There was no treatment received for AE. Outcome of the events was reported as Recovered with lasting effects. No follow up attempts are possible. No further information is expected.

Onset of severe nausea followed by difficulty breathing, uncontrollable incessant dry heaving and coughing, spasms, full body shaking, full body tremors, inability to speak, seizure like reaction, dizziness, tingling in tongue,

Large Swelling of the supraclavicular on the left hand side of the body with pain. Fever, chills, joint pain, bone pane, teeth pain, inability to sleep.

I sat down after vaccination and I felt sore right away up arm and up shoulder, went home, as driving, migraine began, vomiting, couldn't smell. Had to go to Dr and get shot for headache and nausea, vomited for 2 days, loss of appetite, bad body aches. After that I was able to eat and drink bland and it subsided.

April 15- second Covid shot April 22 - first big vertigo spell. Deafness then ringing in right ear April 23 - mild ringing in both ears and thumping, pressure in head May 4th - very noticeable ticking in right ear May 9th - felt sick, off, hard to take a deep breath, pounding head, fullness in ears, ringing, emotional May 11th - ENT visit. Ears clear, hearing fine May 18th - May 23- off and on headaches, difficulty breathing May 24th - Headache that didn?t go away with medicine. Fullness in ear. Nausea May 25th - Sleepless night, stiff neck, very full head. Medicine providing no relief(Excedrin, Sudafed, Flexeril) can feel fast heartbeat, ringing, and pulsation in ears, stiff jaw May 26-28 - light head congestion May 29- headache returns May 30- head congested even after Sudafed. Ears feel ?wet? hard to take a deep breath, lots of yawning. Flushed face and blotchiness on neck. May 31 - Difficulty breathing, ringing in both ears

Rash over entire body -3weeks and counting, swelling of lips in the morning 2 days, swelling of left ankle every night -3 weeks and counting

Patient started with tongue tingling, felt her jaw getting tight and redness to her chest. Patient given Benadryl in COVID pod as well as an Epi Pen. Patient transported to ED and given IV solumedrol and Pepcid. Racemic epi and neb given as well. patient symptoms have since improved.

blurred vision/After my 2nd dose my vision is substantially worse, to where I cannot drive even 3 days later; huge lump under where she received the vaccine; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), 1ST DOSE, single on 23Apr2021 (Batch/Lot Number: EW0170) and 2ND DOSE, single on 14May2021 (Batch/Lot number was not reported), both via unspecified route at 9:50 am, arm left for covid-19 immunisation. Medical history included does wear glasses and mild psoriasis (just uses something topical if she has a flare up) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient historical vaccine includes: flu vaccine from unspecified date for immunization. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient is calling about the Covid 19 vaccine. After she received her first Covid 19 vaccine on 23Apr2021, she had blurred vision starting on Sunday, 25Apr2021. She called the pharmacy and was told that blurred vision was a rare side effect and her vision should clear. She received the second Covid 19 vaccine on Friday, 14May2021 and she experienced the blurred vision again except this time she can't see anything unless it's about 2 inches from her eyes. She doesn't have a job she has to go to but she is a stay at home mom and she home schools her children. She can't even see the text in books. She can't drive, not even to the grocery store. She is asking how long is this going to last. Her arm has a huge lump under where she received the vaccine. The lump is still there from the first vaccine and she has another lump from the second vaccine. Her left arm now has 2 lumps. She thought that might be an allergic reaction but the same lady gave her both injections and stabbed her pretty hard when she gave the Covid 19 vaccine. The pharmacist did tell her she can get blurred vision with any vaccine but she always gets her flu vaccine and she's never had blurred vision before. She received her second Covid 19 vaccine on Friday, 14May2021 in the left arm. She can't find the vaccine record card, she had two vaccine records card because she forgot to bring the first vaccine record card to her second appointment. The NDC for the second vaccine is on her receipt. NDC 59267-1000-01, Lot/Expiry not known for second dose. First Covid 19 vaccine information is in the suspect product field. She received her first Covid 19 vaccine on Friday, 23Apr2021 and she had blurred vision on Sunday, 25Apr2021. She thought at first it was pink eye or conjunctivitis because her vision was blurry and she thought, what did her children bring home to her. Her eyes weren't pink though. She called the pharmacist and he told her it was a side effect. Her vision did get better about a week before the second Covid 19 vaccine but it wasn't completely back to normal. She received the second Covid 19 vaccine on 14May2021 and she experienced more blurred vision on Sunday, 16May2021 but it's much worse and it's not gotten better. She's trying to read from her coffee machine and she can't even see what it says. This can't be normal. Does she need to see an optometrist? She reports she could still drive after her first Covid 19 vaccine because the blurry vision wasn't that bad but this time it's scaring her a little bit. She reports she does wear glasses but only for night time. Her pupils don't dilate well so she tries not to drive at night.The reporter added that around 48 hours after my first dose I began having blurred vision, it got slightly better before my 2nd dose, however, it did not get completely better. After my 2nd dose my vision is substantially worse, to where I cannot drive even 3 days later. The outcome of the event was recovering for blurred vision and not recovered for the other event. The patient was did not required emergency room and physician office visit. Follow up attempts are needed. Further information has been requested.

I woke up to the worst migraine in my right eye the day after my 2nd COVID shot. The next day, I had what looked like blinds (white/black) lines in my vision, then half moon shape in my vision in my right eye for days. Dizziness (I felt like I was on a boat dock), confusion, tiredness and pain the back of the eye for two weeks, numbness of the eyes. I went to the Opthalmologist who stated that I was having an ocular migraine. My Neurologist also said I was having an Ocular Migraine, but I?m stuck in the Postdrome Stage. Gave me Topiramate daily and told me stay away from screens and reading (that means no working and no TV). With the meds, I?m 70% back to my old self, I can drive again, run errands, do yard work, but I can?t work. We increased the dose, still can?t use screens and side effects pushed us to find another drug. Started new drug Amitriptyline on May 30, and symptoms are not disappearing. I have had symptoms (mostly eye numbness, vision issues, dizziness) continuously all day, everyday for 3 39 days and counting

affected her immunity; Hashimoto thyroiditis; test showed higher level of TSH; feeling pain on left side a lymphatic thyroid pain and ear pain.; feeling pain on left side a lymphatic thyroid pain and ear pain.; This is a spontaneous report from a contactable pharmacist (patient). A 40-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT number: EL8982, expiration date unknown) via an unspecified route of administration at arm right on 04Feb2021 at 10:00 AM at age of 40-year-old at single dose for COVID-19 immunization. Patient was not pregnant at time of vaccination. Medical history included in vitro fertilization (IVF). Patient previously received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT number: EL0142, expiration date unknown) via unspecified route of administration at right arm on 13Jan2021 at 10:00 AM at age of 40-year-old for COVID-19 immunization. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included desogestrel, ethinylestradiol (ENSKYCE) within 2 weeks of vaccination. Patient reported that she never had thyroiditis in her life before. On 20Feb2021 at 06:00 AM (about two weeks after 2nd dose), patient started feeling pain on left side a lymphatic thyroid pain and ear pain. Doctor prescribed antibiotics. She was in the middle of IVF process and had all record no thyroid issues before this date. Blood test on 29Apr2021 showed higher level of TSH, on 08May2021 showed higher level and on 14May2021 showed that level become 6.05. Patient made appointment with endocrinologist. And today on 19May2021, she was diagnosed with acute Hashimoto thyroiditis. She had all her thyroid records never had any issues. Patient stated that she was not too sure if this was caused by vaccine but certainly affected her immunity. Patient was prescribed levothyroxine to start from tomorrow (20May2021). Her IVF was cancelled till her TSH level get fixed. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Patient received Ultrasound of thyroid, antibiotics, levothyroxine as treatment for the events. Outcome of event "affected her immunity" was unknown, of the other events was not recovered. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Patient had COVID test post vaccination included nasal swab on 30Mar2021 which was negative. Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on autoimmune etiology of reported autoimmune thyroiditis and event occurrence post two doses of vaccination and elevated TSH levels, the causal role of BNT162B2 vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate

About 12 days after my vaccination, I began to experience ringing in my ears and lightheadedness. On May 9, it began, and it was very loud (more so on my right ear). Then it subsided and became more high pitched but less loud and noticeable, but more noticeable in my left ear. It continued for me as a new background noise for weeks. After some time, I went to an ENT, they did a hearing test, which came back normal. The ringing continued. I saw my primary doctor. He suggested it might be seasonal allergies, despite this never happening to me before during allergy season. He prescribed an OTC nasal spray. The ringing continued and finally subsided during the 1st week of June. Every now and then my ear will feel full and ringing will return, but it?s sporadic now (really only happened twice from 5/30 - 6/3 and not constant anymore. Sometimes noticeable at night now.

doesn't have much of appetite; 148/70 on the blood pressure; allergic response; tongue was a little numb; hard to swallow; Throat was closing up; mouth feeling numb; couldn't really speak; Coughing; super shaky; feet was also feeling numb; face looked swollen; Chest tightness; chest pain; abnormal EKG; Her throat was a little sore; tired; This is a spontaneous report received from a contactable consumer (patient). A 40-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in the left Arm on 17May2021 12:30 (Batch/Lot Number: EW0167) as single dose (at the age of 40-year-old) for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (lot number EW0158) on 15Apr2021 at 12: 50PM (at the age of 40-year-old) in the left arm for covid-19 immunisation and on 15Apr2021 her arm was numb on the side where she received the injection for more than 24 hours, it went numb pretty quickly after the first dose - then it was numb for about 24 hours. It went away completely in two days, but the patient was unsure if that is an adverse reaction. The patient experienced tongue was a little numb on 17May2021 with outcome of recovering , hard to swallow on 17May2021 with outcome of recovering , mouth feeling numb on 17May2021 with outcome of recovering , throat was closing up on 17May2021 with outcome of recovering , couldn't really speak on 17May2021 with outcome of recovering, coughing on 17May2021 with outcome of recovering, super shaky on 17May2021 with outcome of recovering, feet was also feeling numb on 17May2021 with outcome of recovering, face looked swollen on 17May2021 with outcome of recovering, chest tightness on 17May2021 with outcome of unknown, chest pain on 17May2021 with outcome of unknown, abnormal EKG on 17May2021 with outcome of unknown, her throat was a little sore on 17May2021 with outcome of unknown, tired on 17May2021 with outcome of unknown, doesn't have much of appetite on 20May2021 with outcome of unknown. Details as described as follows: Reports she went to sit in the waiting area, after 5 minutes she noticed her tongue was a little numb. She took her card out of her purse, and noticed it was a little hard to swallow, this was within about 8 to 10 minutes. She sat for another 5 minutes and then decided to ask about her tongue feeling numb and was taken to the nurses station. She told them about her tongue, and as she was talking her mouth was feeling more numb and it was getting harder to swallow. As the nurse was talking to her it was like she couldn't really speak. The nurse said this is way past Benadryl and called to another nurse for an Epipen. Caller states she started to cough as her throat felt like it was closing up. They jabbed her with the Epipen within 15 minutes of receiving the vaccine. She got some relief for a couple of minutes and then her body went back into the allergic response. They put her on the oxygen finger machine and then her throat started to close again. They gave another Epipen and then the ambulance arrived. She is unsure how long after she got the second Epipen that the ambulance arrived but it was no more than 5 minutes. They told her they had to call 911 right after giving the first Epipen. When the ambulance team came, she felt like she had novocaine in her mouth, her mouth was super numb and she was super shaky. They said the shaking was normal from an Epipen. Adds her feet were also feeling numb. She didn't know before that the shaking was from the Epipen. She was able to walk to the ambulance and her husband came and the med team was asking him if her face looked swollen and he said her face looked swollen. States her mouth felt like it was moving funny and she was exaggerating her speech trying to make her mouth move right. Adds she was still unaware that this could be an allergic reaction and was just trying to remain calm. At the site, she noticed her vitals on the machine and she saw 148/70 on the blood pressure. Adds it was about the same in the ambulance, it was 148/64. She was not able to collect any information about the Epipen other than they were yellow with a blue cap and they held it in her leg for three seconds. No lot or expiration date known for the Epipens. In the ambulance she was treated with Intravenous (IV) steroids and dose of Benadryl 50mg. As she was being transported to the hospital, she started to have chest pain. They did an EKG in the ambulance with no remarkable findings. Adds she has a follow up with her Primary Care Provider (PCP) today. When she arrived at the Emergency Room (ER) they monitored her for a couple of hours. She had another EKG at the ER and was told that it was normal so they released her. She has no product information for the steroids or the Benadryl that she received. No lot or expiration date known. When she got home everything was calming down. Her throat was a little sore and she was tired. The next morning her chest was still tight. She called the doctor who told her to just relax and come back to the ER if she has palpitations or difficulty breathing. Mentions she got the results of the EKG in ER now, and it said it was abnormal as compared to a previous EKG she had, and something about the T axis. Adds now she doesn't have much of appetite and her tongue still feels a little off. Caller interrupts the call to say her doctor just called and she needs to go. Unable to complete the report at this time. The outcome of other events was unknown. No follow-up attempts are needed. No further information is expected.

Neuropathy initially in right arm, then subsided after two days. Neuropathy/tingling of fingers and toes returned with increasing sensation on May 21, 2021. On friday May 28, 2021 lips are now tingling and more feeling of full body tingling and weakness followed by close to fainting spells. Sunday night worst headache of life, followed by chills, almost fainted, went to ER and all tests normal. Neuropathy has not left. Sent home with no answers. Wednesday June 2, 2021 tingling of hands, feet and lips more extreme followed by moments of shortness of breath and fainting. Went back to ER all vitals normal. Two days later I have missed two days of work because my body is so weak and the nreopathy remains. Please help. I cannot continue to live with these symptoms. I had zero health issues leading up to this and all of the dr's are stumped.

Slightly lightheaded; Slight ringing in my ears; Resting heart rate began to increase; Facial/neck flushing; Became hot; This is a spontaneous report from a contactable nurse, the patient. A 40-year-old non-pregnant female patient received first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6200), via an unspecified route of administration on the left arm on 17Mar2021 at 14:15 (at the age of 40-year-old) for COVID-19 immunisation. Concomitant medications (within 2 weeks of vaccination) included vitamin E, hydrolyzed collagen, vitamin C, biotin. She has no known allergies to any medications, food, or other products. She did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine and was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, she had not tested positive for COVID-19. On 17Mar2021 (within 2-3 minutes after the vaccination), she became slightly lightheaded with a slight ringing in her ears; Her resting heart rate began to increase from 70 beats per minute up to 131 beats per minute with facial/neck flushing and she also became hot. The symptoms resolved within the next 2-3 minutes. It was also confirmed that she was 5 hours out from receiving the vaccine without further issue. No therapeutic measures were taken to treat these events. The clinical outcome for the events became hot, facial/neck flushing, resting heart rate began to increase, slightly lightheaded, slight ringing in her ears was recovered on the same day (17Mar2021). No follow-up attempts are needed. No further information is expected.

Mild metal taste in mouth approx. 1 minute after shot was administered; Soreness in left arm, around site injection started approximately 6 hours after administration; spread to about 3 inches outward around from site of injection; Migraine started around 24 hours after shot was administered, with pain concentrated behind right eye; Fatigue; ended up sleeping nearly 12 hours; This is a spontaneous report received from a non-contactable consumer or other non hcp. A 40-years-old non pregnancy female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EW0186), via an unspecified route of administration in Arm Left on 28May2021 15:00 (age at vaccination 40years old, No pregnancy at time of Vaccination) as single dose for covid-19 immunization. Medical history included lactose intolerance from an unknown date and unknown if ongoing. Prior to vaccination, the patient was diagnosed with covid-19. Concomitant medication(s) included Vitamin C, Vitamin D, Calcium Citrate, Iron taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination the patient was not diagnosed with covid-19. The patient received other medications in two weeks. On 28May2021 21:00 the patient experienced mild metal taste in mouth approx. 1 minute after shot was administered; dissipated a few minutes afterward. Soreness in left arm, around site injection started approximately 6 hours after administration; spread to about 3 inches outward around from site of injection; no swelling. Migraine started around 24 hours after shot was administered, with pain concentrated behind right eye. Fatigue; ended up sleeping nearly 12 hours. After 42 hours, migraine has gone away; remaining symptom is soreness - now reduced to half the area and still concentrated around site injection area. Patient was not received treatment for the events. Since the vaccination, the patient has not been tested for covid-19. The clinical outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.

I had an allergic response that included itchiness, watery eyes, congestion... then settled into bronchitis. I still have the bronchitis.

3:30 am that night I got shaking fever/chills. I expected that but about 5 days after the shot the inside of my mouth was in a lot of pain. A fever blister formed on my lower lip (left) and the inside of my mouth felt raw. It has been going on 2 days now- it?s hard to eat and hurts to talk. My gums are sore and I can feel raw spots on the roof of my mouth-like blisters.

Patient complained of tingling of the mouth and throat "like when I have peanut allergy". Patient reported that she took a Zyrtec and denied difficulty swallowing or breathing. Vital signs stable. Complained of nausea and that her chest felt heavy. EMS called and was taken to the hospital.

Facial hives Eye lid swelling Symptoms began at 630pm 2 25 mg tablets (50mg total) taken orally at 7pm Symptoms resolved within 4 hours

speech difficulties (couldn't think of words, slurred words); Blurry eyesight; fever; clammy skin; headache; fatigue; itching skin; loss the ability to focus eyesight on phone, computer screen or books.; This is a spontaneous report from a Non-Contactable consumer (patient). A 40-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL3302), via unspecified route of administration in the Left arm, on 25May2021 at 10:30 AM, as a single for COVID-19 immunisation. Medical history included Hypothyroid. Concomitant medications included armour, liothyronine and spironolactone. The patient had no known allergies. On 25May2021 at 02:30 AM, the patient experienced Blurry eyesight, fever, clammy skin, headache, fatigue, itching skin, speech difficulties (could not think of words, slurred words), loss the ability to focus eyesight on phone, computer screen or books. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, the patient had not been tested for COVID-19. The patient was not tested for COVID-19 post vaccination. The patient did not received treatment for the events. The outcome of the events was recovered with lasting effects. No follow-up attempts are possible. No further information is expected.

The evening following the 2nd dose of covid 19 vaccine my arm was sore and I was tired. That night it progressed into a fever of 104, severe body aches in almost all my joints, headaches, bradycardia and body chills. The fever was minimal reduced by switching Tylenol and Ibuprofen every few hours to about 102. Fever, chill and body aches started to subside in about 24 hours. Today I have sore throat, pressure/fluids in ears, slight chest pains and bradycardia, light headache and swollen lymph nodes in throat , inject site is still sore but most bothering is dizziness that is setting in.

AFTER THE FIRST VACCINE: HERPES BASED BLISTERS IN MOUTH TO THE POINT THAT TAKING OR EATING WAS VERY PAINFUL. SAW MY PA ON 03/25/21. VALTREX PRESCRIBED. BLISTERS WERE MUCH BETTER WITHIN 48HOURS. 03/27/21 UNEXPECTEDLY HAD MY PERIOD. I HAD JUST FINISHED UP MY PERIOD WHEN I HAD THE VACCINE ON 03/18/21. THIS PERIOD WAS UNLIKE ANY OTHER. THE BLEEDING WAS INCREDIBLY HEAVY, FULL OF CLOTS AND LASTED 9 DAYS. MY USUAL CYCLE IS 5. AFTER SECOND DOSE: ANOTHER UNEXPECTED PERIOD. THIS TIME NOT AS HEAVY, NOT AS MANY CLOTS AND DID NOT LAST AS LONG. SORE UNDERNEATH ARM AND LYMPH NODE UNDER ARM SWELLED.

Lips swelling, itchiness, dryness, peeling and redness 2 weeks after vaccine, went to the doctor and was told to take a histamine for a few days and if it doesn?t improve to take a steroid.

Fever over 103°, chills, severe headache with light sensitivity, rash halfway down my arm on the arm where injection was given

12/19/2020-12/20/2020 only experiences soreness of left arm where vaccine received. Woke up early morning 12/21/2020 with moderate swelling of eyelids, face, lips that progressed over several hours before seeking care at Hospital ED. Received IV Benadryl and IV solumedrol. Prescribed oral prednisone dose pack to start next day. Symptoms mostly resolved by that evening.

Taste buds went numb, metallic taste, slight swelling of throat, itchiness all to upper body, joint pain, and pain at injection site. Lasting about 12 to 24hours. Antihistamines treated at home.

I received the 1st Covid vaccine on December 23rd, 2020, then I was exposed to the coronavirus on the 25th of December, then I started having symptoms at 3:30 am on December 29th I went and got tested that morning and the test was positive for covid-19. I then went home to quarantine. I have experienced fever, body aches, headaches, nausea, diarrhea, sinus pressure, chills, loss of taste and smell, weakness and fatigue. But have been able to continue to recover at home.

Immediately post-vaccine, face felt hot and tingling, lasted 45 minutes. Nausea 12/26-12/27. Rash on flexural of both arms, started with just left then progressed to both arms 12/27; achy feeling still; "gross feeling;" swollen lip with blister, started 1/3; left supraclavicular lymph node swollen

At around 0910, employee reported tingling on tongue and roof of mouth while in the monitoring area post vaccination. RN obtained V/S: 122/76; pulse 78; resp 18; pupils equal and reactive; skin pink. Employee was alert and oriented. She reported slight reaction about 30min. post vaccination. Dr. was notified and assess the employee. Dr. ordered Benadryl 25mg PO at 1001. This was administered by RN. Employee was monitored for another 20 minutes and then was aloud to leave. Employee was feeling better before leaving. She was instructed to seek medical attention if symptoms returned or new symptoms occured. She verbalized understanding.

Fatigue; Myalgia; Injection site pain; Headache (frontal)/Worsening headache; Joint pain; Chills; Nausea; Vomiting; Worsening headache w/ photophobia; Subjective fever; This is a spontaneous report from a contactable physician (patient). A 41-year-old female non-pregnant patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=59267-1000-1 /EH9899), via intramuscular on 28Dec2020 09:45 at single dose on her right arm for Covid-19 immunization. Medical history included psoriasis. The patient had no known allergies. Allergies to medications, food, or other products was none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. It was reported that 6h after administration on 28Dec2020 16:00, the patient experienced fatigue, myalgia, injection site pain; 10h after (in addition to above) on 28Dec2020, the patient experienced headache (frontal), joint pain, chills and 12-28h after (in addition to above) in Dec2020, the patient experienced nausea, vomiting, worsening headache w/ photophobia, subjective fever, joint pain. The patient was not received any treatment for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19, since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovering.

got a very metallic taste in my mouth; sleep a lot; tired; This is a spontaneous report from a contactable healthcare professional. A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140/ELO140), via an unspecified route of administration, at the left arm on 30Dec2020 06:30 at a single dose for COVID-19 immunization at a hospital. Medical history included seasonal allergies and doesn't take medications. On the same day of 30Dec2020, about an hour after vaccination, patient got a very metallic taste in mouth, which lasted for about 12-18 hours and did sleep a lot, which she expected, but woke up about 11 at night and still had it and it was gone. Patient knew she slept longer than she normally does, went to bed at 1PM and slept until 11PM, which is not usually normal. Was up for about an hour or two and then went back to bed until 8AM of 31Dec2020. Patient was concern was if it was some type of reaction that it would mean she was going to have a stronger reaction to the second one and stated it was irritating but not a huge deal. Patient also felt tired and expected it as she worked five 12-hour shifts in a row. Patient was not sure if the metallic taste was connected to the COVID-19 vaccine. No prior vaccinations within 4 weeks. Outcome of the events was unknown.

Pfizer vaccine administered to associate 12/21 at 9:46am. Felt healthy and well prior. Felt fine until about 3pm. Just typical arm pain. Moderate/Severe Fatigue set in around 3-6pm. Needed to nap from 4-5pm (extremely unsusual). Felt fine the next day. Moderate congestion in ears starting around the same time (6 hours after) and is persisting 30 hrs later. Feel like my ears will not pop and trying to yawn a lot. Also felt pretty bad sinus congestion starting at 7pm 12/21 (10 hrs after vaccine). Could not breathe through nostrils. Treated with sinus rinse and sudafed.

I Initially just had a sore left arm which felt better the next day. I woke up the morning after the Vaccine (1/6/21) and experienced right jaw pain which extend it to my ear which was worse during chewing and talking. Today on January 7 it is still present however seems milder

Developed shortness of breath, swelling of tongue, persistent cough within 5 minutes of vaccination. Was treated with EpiPen and kept in ER for observation overnight. Symptoms resolved.

Patient received COVID-19 vaccine. After receiving vaccine patient c/o nausea and feeling "something in throat". Vital signs obtained at 1853 175/96, HR 68, temp 98.3 and o2 sat 99%. Repeat VS at 1903 167/103, HR 78, O2 sat 100%. Having pulse ox desaturations while speaking. Patient transported to ED in stable condition. Patient monitored in ED with resolution of symptoms and was discharged.

Employee received Pfizer COVID-19 vaccine and subsequently developed full body itching and reported feeling like tongue was swelling. Patient was given 50 mg PO Benadryl. No improvement patient was escorted to ED by RN for evaluation

Oral dysaesthesia - scratchy throat morning after vaccination, then developed tongue burning and progresses to full mouth Fatigue, headache, body aches

1st event: Metallic taste in mouth; then felt like I had a 'fat lip' on left lower lip; and left half of tongue- tip only- went numb Injected with 50mg of Benadryl in my left upper thigh 2nd event: 4.5 to 5 hours later- Metallic taste returned {Liken to cold house key metallic taste} in center of tongue- width of 1-2 mm, taste lasted 30-45 seconds. Left side of lips went numb (upper and lower) with lower again feeling swollen. Left upper part of tongue again went numb. Took 25 mg tablet of Benadryl. Odd feeling in tongue lasted for a few days after vaccine.

employee received the vaccine at 3:45 PM, and at 4:00 PM began feeling a sensation in her mouth of having lots of saliva. Did not get nauseated. Also experienced metallic taste in mouth. 5 minutes later felt dizzy, then 5 minutes later felt shaky BP was 159/93, HR 107 felt well enough to finish out shift, and went home. Following day felt lethargic, but recovered from that at home.

Tingling in injection arm, fingers; tingling in face; tongue swelling 30 minutes- 1 hour after vaccine. Visited immediate care; received IV of Benadryl, Pepcid & Steroid.

About 5 min after getting the first dose, I felt numbness in my left hand. I was monitored for 60 min and they did blood pressure and oxygen check. about 10 min in, I felt a little funny in my mouth, like a little bit of swelling, but never to the point of issue with breathing or swallowing. Numbness seemed to have subsided by the 60 minute time and I went home. No other symptoms.

cheeks were swollen; when I brushed my teeth, i felt a severe burning sensation inside my mouth and the inside of my mouth started to swell; when I brushed my teeth, i felt a severe burning sensation inside my mouth and the inside of my mouth started to swell; so tired; This is a spontaneous report from a contactable healthcare professional, the patient. A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) solution for injection intramuscular in the left arm on 26Dec2020 at 09:30 (at the age of 41-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included allergic reaction with known allergies to sulfa, seafood. Concomitant medications included acetylsalicylic acid/caffeine/salicylamide (EXCEDRIN) and paracetamol (TYLENOL). The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient stated, "I just finished a night shift from work and got home on 02Jan2021 around 07:45 when I brushed my teeth, I felt a severe burning sensation inside my mouth and the inside of my mouth started to swell. I didn't think much of it since I was so tired but then woke to get ready to work then my mouth and cheeks were swollen (02Jan2021 at 16:00) and barely could open my mouth." No treatment was provided for the events burning mouth, mouth swelling, cheeks were swollen and so tired. The outcome of the events burning mouth, mouth swelling, cheeks were swollen and so tired was not recovered. Since the vaccination, the patient has not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Approximately 5 minutes after receiving vaccine, tongue began to swell with itching to lips and cheeks and stiffness to jaw. Notified vaccine team. Received Benadryl IM with return to baseline and transported to the ER for monitoring. Received 4 days of Prednisone and Pepcid PO.

41-year-old woman who presents to the office on 1/12/2021 for fatigue, congestion of nose and eyes and lack of taste and smell. Patient's initial symptoms started on 1/8/2021 with some rhinorrhea. The following day on 1/9/2021 she went to the gym feeling fine. That evening she felt fatigued and attributed to her workout earlier in the day. The next day she developed a severe headache with fever, sweats, chills and body aches. Yesterday on 1/10/2021 she developed nasal congestion and eye symptoms. Patient presented to the office today on 1/12/2021 for testing and was Covid positive. Patient had a positive Covid test on 11/11/2020 with mild symptoms of headache, fatigue without congestion or loss of taste and smell. At that time the duration of her symptoms was 3 days. She had the first Pfizer Covid vaccine on 12/18/2020 with minimal muscle soreness. She had the second Pfizer Covid vaccine on 1/8/2021. Patient works in administration of a medical facility. She has minimal contact with clinical staff and patients. No one in her office has had Covid symptoms or infection. Patient's other contacts are at home and the gym. She does attend a gym class with 10 other participants. She does not know whether anyone in the gym class has had symptoms.

Started coughing at 8:20 thought just a dry throat. By 8:25 throat became itchy. Assessed by EMT. Benadryl 25 mg po given at 8:40 and manager called to take her from work due to Benadryl

I developed a sharp pain on the back side of my left neck area; I developed a severe earache, which began to subside within about 2 days; my upper left molar started aching (toothache); I had a sharp intermittent pain in my left jugular/carotid neck area; felt a little "tipsy; I had intermittent numbness and tingling in my left jaw area; I had intermittent numbness and tingling in my left jaw area; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received the first dose of BNT162B2 (Lot number: EK5730), via an unspecified route of administration on 21Dec2020 at single dose in the left arm for COVID-19 immunization. Medical history included allergies to Sulfa antibiotics. The patient's concomitant medications were not reported. The patient previously took meperidine (DEMEROL) and experienced allergies. Within an hour of receiving the vaccine, the patient had a sharp intermittent pain in her left jugular/carotid neck area and felt a little "tipsy". This continued for about one day. Then last week (approximately 28Dec2020), her upper left molar started aching (toothache). This subsided within about 2 days. Then on 30Dec2020, she developed a severe earache, which began to subside within about 2 days. Around 31Dec2020 through 04Jan2021, she had intermittent numbness and tingling in her left jaw area. Last night (05Jan2021), she developed a sharp pain on the back side of her left neck area. She went to the doctor on 04Jan2021, and no treatment was prescribed. She began self-medicating with an old prescription of prednisone on the evening of 04Jan2020 due to being fearful of developing Bell's Palsy. Most of her symptoms have now improved after beginning the prednisone. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovering.

Onset of "kaleidoscope vision" at 10:50 AM, followed by headache, nausea, light sensitivity, and difficulty focusing eyes (symptoms of ocular migraine). Severe symptoms lasted 5 hours, mild symptoms lasted through the evening and next day (today I still have a mild headache and nausea). I have previously had 1 migraine (~5 yrs prior) in the setting of repeated fume exposure during a renovation at my workplace, no other history of migraine.

Dose 1 -Headache for 4 days, and fatigue Given 12/21/2020 @ 0900am Dose 2-headache, shaky, fatigue, light headed, blurred vision, high blood pressure and mental fogginess Given 01/11/2021 @ 1430pm

positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; After the shot i have headache, sorethroat, cough and cold till this date; After the shot i have headache, sorethroat, cough and cold till this date; After the shot i have headache, sorethroat, cough and cold till this date; After the shot i have headache, sorethroat, cough and cold till this date; A 48-years-old non-pregnant female patient, receivedBNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, in left arm, on 18Dec2020 (at the age of 41 years-old) as a single dose for COVID-19 immunization. The vaccination was administered at a pharmacy/drug store. Medical history was not reported. Concomitant medication included sertraline hydrochloride (SERTRALINE HYDROCHLORIDE). The patient had not received any other vaccines within four weeks prior to the vaccination nor received any other medications withing 2 weeks prior. It was reported that the patient had been tested for COVID-19 prior to vaccination and was negative. On 18Dec2020, the patient experienced itchy sore eyes one hour after vaccination, sore and itchy arm for 5 days, headache, swollen sore throat, tiredness all 5 days after. The patient was not hospitalized nor received treatment for the events. The clinical outcome of the events of Itchy, sore eyes 1 hour after, sore and itchy arm for 5 days, headache, swollen sore throat, tiredness all 5 days after, was not recovered., the outcome of the COVID-19 positive was unknown. It was reported that the patient tested positive for COVID-19 via nasal swab, post vaccination on 31Dec2020. No follow-up attempts possible. No further information expected. Lot/batch number was not provided and unable to obtain

24 hours after the injection I had a sore arm, developed slight body aches and headache. Since the injection I had been getting headaches almost daily, mostly on my right side of my head. On Dec. 5, 2021 I noticed I was getting a sore eyebrow. Later that evening ok noticed swollen lymph nodes throughout my scalp, face, ear, jaw, neck and chest. My eyebrow also started to swell and was slightly pink. When the swelling was worse the next day - I went to urgent care and saw A doctor that diagnosed me with facial cellulitis. After a couple days my eye was not getting any better and started to itch severely. Called to urgent care over the weekend and takes to one of the providers who said to use cold compresses and elevate my head as much as I could. On Dec. 11, 2021 I called back to the provider I had seen on Dec. 6 - he told me he believed I had developed shingles and to go to the eye doctor that day. I saw a doctor on Dec. 11 & was diagnosed with shingles. They started me on antivirals along with the antibiotics they had prescribed on Dec. 6.

POST VAC. SHOT C/O OF THROAT TINGLING, TONGUE FEELING HEAVY AND NUMB. EMS PRESENT. 1427: VS: BP: 143/91, O2 SAT R.A.: 98%; P: 78. 1435: VS: 144/88; 02 SAT R.A.: 98%; P: 78; 1440: LEFT SITE, NO OTHER COMPLAINTS.

Received the vaccine on a Wednesday afternoon. That evening I developed body aches, which got progressively worse over the course of the following day. I developed a persistent headache on Thursday that stuck around until Sunday. On Saturday morning I woke up feeling ok, still had the dull headache, but was ok enough to be up and around. At approximately 10:30 Saturday morning I was hit with stroke symptoms. I had weakness in my left hand, tunnel vision, couldn?t understand words that were spoke to me and was aphasic with garbled speech. Went to local ER and was worked up for stroke. Symptoms resolved Within approximately 45 minutes. All tests, lab results ok.

Patient developed loss of taste, fever 100.1, shivering , muscle ache and weakness within 24 hours after second dose.

Severe aches, chills, headache, stomach cramps, nausea, vomiting, diarrhea, sweats, eye pain, fatigue, skin sensitivity. Treated with Tylenol and CBD lotion. Mostly resolved within 36 hours of onset.

Pt Complained of numbness/tingling around the mouth . Red rash . Tenderness on the injection site/lower arm for 5 days.

Approximately 20 minutes after the shot I became dizzy and nauseous. Followed my my upper lip and nose tingling and then the whole face tingling and numb feeling as if I had gotten a novacaine shot. This has continued all night but is currently more on my left side of face and down left forearm tingling/numb.

Pt came to the COVID vaccination clinic today to receive her first dose of the Pfizer vaccine: EL3246. Pt states "I am very nervous about getting this". Pt brought a co-worker with her for support. Pt has "MS and Anxiety". Pt received her vaccine without any difficulty. While sitting for her observation time after the vaccine she began having some "tingling of her tongue and face feels hot". Pt denies any breathing difficulty. Pt states "I am not sure if this is from my anxiety or a reaction". Pt is drinking water with honey. Gave her some fresh water and monitored. Checked on her a couple minutes later. She was in the chair and then up to walk and was concerned "my legs are feeling tingly and a little cold". When asked if she ever takes BENADRYL for her previous medication reactions Pt states "yes". I asked her if she has someone who can drive her home and she made arrangements for her co-worker to take her. Gave Pt BENADRYL 25 mg po one for potential reaction symptoms at 15:05. Moved Pt to a quieter place to monitor and observe. Gave her a warm blanket and some juice. Vitals at 15:18: BP= 116/68, HR=80 Resp rate 16-18. Pt is alert, oriented and states "feeling a little better". Tingling sensation is "leaving". Pt denies any respiratory symptoms. Monitored by RN. Pt set up with telephone call with Employee Health Provider, PAC. Determined this is most likely symptoms caused by her anxiety. Pt left ambulatory with her co-worker and symptoms were resolved.

Extreme hot flash that felt like needles all over the body, knees felt like they were on fire, lips and tounge were tingling, bad taste in mouth, elevated blood pressure and heart rate, and dizzy. Dissipated after about 30 minutes, and left a headache.

1600 hrs. Stated throat burning and felt like it was closing up, hot flashes, ears ringing, and warm. Vitals monitored every 15 minutes with first set being within range with the exception of elevated BP at 150/90. Benadryl 25 mg given PO. Sitting in chair, able to answer all questions with no apparent distress in speaking. Continued symptoms above at 1630 administered an additional 25mg benadryl PO . Alert and oriented, able to call spouse for a ride home. Due to continued symptoms rapid response team was called for evaluation and took over care to be transferred to ER for further monitoring and evaluation.

I was approached by a person in the center at approx 1000 stating she had an employee that received their first COVID vaccine and was not feeling well. I went over to find the employee sitting in the person's office in a chair. She was able to tell me she received her first COVID vaccine approx 30 mins ago. She stated she stayed there for the 15 mins after the vaccine with no reaction. She is now having ringing in her ears, feeling lightheaded, hot, nauseaus, and "I feel like I am in a cloud." She denies allergies or past hx of vaccine reactions. Denies hx of anaphylaxis. She denied any sob or chest pain. Employee was holding her head. She stated she had only had some coffee and juice today and was feeling hot. BP was taken and was 112/90 and she is not tachy and no resp distress observed. Patient was able to speak to me in full complete sentences initially. Another person came over and the employee was asked if she could stand and walk. Employee stated she felt she could stand and walk and when she did this she had to hold onto something to avoid falling and she was sat back down. Emergency services was called and employees speech was slow and almost slurred at times. Emergency services arrived and transported employee.

Fatigue; Dry mouth; Low grade fever; Chills; Headache; Itchy rash at injection site; Itchy rash at injection site; Soreness at injection site; This is a spontaneous report from a non-contactable nurse (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685), via an unspecified route of administration on 31Dec2020 12:45 at left arm, at single dose for covid-19 immunization. Medical history known allergies: penicillin, chocolate from an unknown date. Concomitant medication included acetylsalicylic acid (ASPIRIN) and Birth control pills. The patient previously took erythromycin and known allergies: Erythromycin. The patient was not pregnant at the time of vaccination. The patient experienced fatigue, dry mouth, low grade fever, chills, headache, itchy rash at injection site, soreness at injection site on 31Dec2020 15:00. No treatment was received for all events. The outcome of the events was recovered on an unspecified date. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect. No follow up attempts are possible. No further information is expected.

Within ten minutes, I had a massive headache and the roof of my mouth went numb. Within one hour, I had severe bruising, dark purple, the size of a half dollar, that JUST went away and I am due on 1/17/2021 for my next vaccine. I had no pain, only dark purple bruising and swelling. The headache and mouth issue went away after three days.

About 10 minutes after getting my vaccine I noticed the roof of my mouth itching as well as my tongue and back of my throat. I waited to see if it would go away and then a couple minutes later noticed my lips started itching and swelling and from there it just got worse. I told the nurse practitioner that I think I was having a reaction, she had me take a seat told her my entire mouth throat & lips felt swollen and itching and she looked and said it was full blown anaphylaxis reaction. Administered EpiPen, benadryl and called ambulance where they took me to medial emergency department.

Headache, Myalgia, Fever, HYPERtension, employee stated after receiving vaccine had body aches, joint aches, photophobia, headaches, fever, hypertension Narrative: Employee stated H/A, body aches, joint aches, photopobia, fever, hypertension BP 170/100, employee sent to to ER due to elevated b/p. denies any other symptoms.

Immediately experienced racing heart and severe dry mouth. My KARDIA 6-lead EKG stated "Possible AFib" and heart rate was 145-155. Blood pressure became elevated much higher than baseline (Normal is 90/60). Paramedics came to evaluate and performed numerous 12-lead EKG's and noted multiple Premature Ventricular Contractions and transported me to the hospital where I was observed and consulted on from ED Physician. Later was evaluated by electrophysiology cardiologist with echocardiogram and EKG. Multiple physicians have advised not to get second vaccine.

I started itching while being monitored post vaccine administration within the 5 minutes of the vaccine being administered. The itching was everywhere including my tongue and throat, since this is my workplace and I was working I had to go home and was given Benadryl to take upon arrival, the Benadryl did not help so I did a virtual visit with a physician who recommended that I increase the dose of benadryl at the same time I called my PCP to inform them of the issue they ordered, Atarax 25 mg every 6 hours plus taking an over the counter antihistamine.

Within 25 minutes of receiving the vaccine, my left arm became very heavy and there was a tingling/neuro sensation in left wrist/hand. A pressure began in the anterior of my throat which increased gradually. I sought treatment in our Urgent Care just after noon that same day. The Provider monitored my vitals which were good and administered liquid Pepcid. Said Provider chose not to give Benadryl as I had taken Zyrec that morning for my allergies. I was discharged from the Urgent Care and went back to work at 1245. At 1730 hours, I had a slight headache above my right eye and extreme right-sided jaw pain with tooth sensitivity. These lasted for only 10 minutes. At 1830, the anterior and bilateral portions of my throat began to feel "prickly" and I developed a wheeze. I used an albuterol inhaler to relieve the wheeze successfully. At this time I also developed an itchiness throughout my whole body, worse on left side than right side. I took 100mg of Benadryl with no relief. At 0300, I took another dose of 100mg of Benadryl with no relief. I also took an itch pill/antihistamine of my husband's which provided no relief. At 0800, I took 20 mg of Zyrtec. At 1030, I took 100mg of Benadryl. I continued to use Benadryl throughout the day, every 4-5 hours. At 1800, I had a fullness in my throat, a tightness in my chest and my left shoulder blade felt almost numb. I also had a hoarse voice which passed by the next morning. The chest tightness was intermittent over the next day or two. On Friday, the itchiness had improved some but was still prominent. I continued to use Zyrtec and Benadryl throughout the day. My Primary Doctor called in Prednisone if needed. By Saturday morning, I felt MUCH better. Today is Sunday and I am no longer itching and I feel so much better today.

Fatigued; Sore in her throat; Lost her voice (hoarse); Reddish nose; Intermittent coughs; she went to work to a COVID unit which she usually didn't do; described her symptoms as a chest cold; Feeling strange like coming down; swelling and soreness in the injection site for a day or two; swelling and soreness in the injection site for a day or two; This is a spontaneous report from a contactable nurse reported for self. This 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) via unspecified route of administration on 07Jan2021 13:30 PM at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not provided. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) for COVID-19 immunization on an unspecified date. On 07Jan2021 after second dose vaccination, the patient started experiencing swelling and soreness in the injection site for a day or two. On 08Jan2021 the next day, she went to work to a COVID unit which she usually didn't do. On 08Jan2021 the next day after her shift at 15:00 PM, she started feeling strange like coming down. On 09Jan2021, she felt totally fatigued. The symptom that bothered her the most is the sore in her throat which has gone 10Jan2021, she said she lost her voice (hoarse). She was also experiencing a reddish nose and intermittent coughs. She described her symptoms as a chest cold. The patient also stated she didn't have fever or chills. She's afraid she might be sick. The outcome of event the sore in her throat was resolved on 10Jan2021. The outcome of other events was unknown. Information about lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported chest cold cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Shot 1- shaky, weak, increased heart rate, mild swelling of mouth tongue and throat - resolved in a day Shot 2 a shaky, weak, increased heart rate and blood pressure, moderate swelling of face, tongue, throat, intermittent dizziness and Left eye blurriest, left facial decreased sensation and pain from mouth to ear, pain behind Left eye - symptoms wax and wane throughout the day

5 minutes after vaccine- hot/dizzy, lasted less than 1 minute. Right side neck pain/ache, left arm pain/ache- lasted less than 5 minutes. 30 minutes after vaccine rash, itching- lasted 2 days. 1 hour after vaccine- severe headache lasted 4 days. 4 hours after vaccine- ears/throat itching. Took Benadryl 50mg, Tylenol 1000mg, Albuterol Inhaler 2 puffs, and Famotidine 20 mg 4 hrs after vaccine.

Had sore arm quickly after Chills 24hours after 30 hours after woke up with serve left side jaw pain into cheekbone and facial swelling on left side of face. Sunday called my employee health who sent me to ER. Given steroids for 4 days for swelling and pain to left cheekbone and jaw area (especially at the joint) noted mild left side throat swelling on exam (internal)

tightness in my chest; sob/shortness of breathe; headache; chills; body aches; extreme fatigue; bloating; shakes; blurred vision and couldn't focus on my cell phone; tachycardia/heart rate went up; dizziness/ felt dizzy; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: ER9231), via an unspecified route of administration in the right arm on 06Jan2021 at 10:00 AM at a single dose as COVID-19 vaccine. Medical history included anaemia and anaphylactic reaction to shellfish. The patient was not pregnant at the time of vaccination, did not receive any other vaccine within 4 weeks prior to the COVID vaccine, and had no other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to the vaccination and was not tested for COVID-19 post vaccination. There were no concomitant medications. On 06Jan2021, within 2 hours (at 12:00 PM), the patient experienced blurred vision, within 4 hours tachycardia and dizziness, within 8 hours headache, chills, body aches, and extreme fatigue, and within 12 hours, tightness in her chest, SOB, extreme fatigue, and body aches. As treatment, the patient received ibuprofen. The patient stated that she had a pretty severe reaction. She also informed her employer but nobody helped. They observed her 15 mins. post-vaccination. She was fine within 15 minutes. It was also reported that within 2 hours, she had blurry vision, tachycardia, and felt dizzy. In the middle of the day, she felt chills, shivers, dizziness, bloating, and headache. The patient also stated that she experienced shakes and taking a shower hurt, also, chest was tight all day. It was further reported that when she was sent back home from work, she started having a severe body ache, fatigue, chills, and shivers. She experienced tightness in her chest , shortness of breath, and she could barely get out of bed. This lasted all day. She still had the blurred vision and couldn't focus on her cell phone. She felt a little bit better today but was still not 100%. She contacted her MD who advised her to report this to Pfizer. The patient wanted to know if it was safe to receive the second dose of COVID-19 vaccine. It was reported that the events resulted in a doctor or other healthcare professional office/clinic visit. Outcome of the event 'Vision blurred' was not recovered, for the event 'Tremor' was unknown, while for the rest of the events was recovering. The case was reported as non-serious (did not result in death, was not life-threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and did not result to any congenital anomaly/birth defect).

Mild skin rash/welts on face. 1cm sized itchy swelling on bottom lip. puffy eyes (mild) mildly scratchy thoat. Mildly scratchy eyes. Was better by morning and gone by the next evening. Did not take Benadryl.

22 hours after the second dose started to have an allergic reaction, hives all over back and chest and neck. Took benedryl and pepcid at home OTC. The next morning woke up with hives, flushed feeling, and chest/throat tightening. Went to the ER was administered iv medications. Went home. 4 Hours later started again with chest and throat tightening and swelling of the eyes. Kept having break through reactions when medications were wearing off. The ER md that I saw called in some home medications that I started taking. Pepcid and Prednisone. 7 days later still having to take benedryl and pepcid due to eye itchiness and swelling.

5 min after dose admin c/o of cheeks feeling funny, L eye puffy. HR 138, BP 140/80, pulse ox 98%. A/o & talking w/friend. Over the course of 30 min cheeks feeling improved but felt that cheeks remained a bit numb. L eye puffiness gone. Left amb after 45 min HR 96, BP 112/70, pulse ox 99%.

tip of tongue numb; Metallic taste; lower left lip felt swollen; This is a spontaneous report from a contactable other health care professional (patient). A 41-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284 and expiration date not provided), via an unspecified route of administration (Right arm) first dose on 02Jan2021 10:30 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 02Jan2021, the patient experienced metallic taste, lower left lip felt swollen, and tip of tongue numb. The patient was treated with Injection 50 mg Benadryl L thigh. The outcome of the events was recovered in Jan2021. Facility where the most recent COVID-19 vaccine was administered in Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient did not tested for COVID-19.

Decided to get second vaccine 1/11/21 even though she was still getting hives from 1st dose. Developed swelling on inner canthus L eye. Saw Dr. 1/14/21 and famotidine was ordered. This reduced hives. In 1/16/21 developed swelling of R inner canthus. Took Benadryl and famotidine hs on 1/17/21. Took famotidine 1/18/21 before work, but developed hives under arms and tongue began to swell that evening. Took another dose of famotidine. Tongue improved within 40 minutes but L side of face began to swell. Took Benadryl 50mg. Facial swelling improved but did not go away. Called Dr. this am and was ordered a Medrol dose pack. If this is not effective then she will be referred to Dr., allergist.

Within 2 hrs- blurred vision, dizziness, sore arm Within 4hrs- tachycardia, lightheaded, headache, fatigue Within 6hrs- headache, extreme fatigue, SOB Within 8hrs- tightness in chest, extreme fatigue, body aches, chills plus all others listed

tingling in her right arm; I woke up on Monday very tired; she had symptoms of bells palsy; This is a spontaneous report from a contactable consumer (patient). This 41-year-old female (no pregnant) patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1686) on 05Jan2021 10:15AM at Upper Left Arm for COVID-19 immunization. Medical history and concomitant drug were not reported. She said she got Botox injections in her forehead, as well as, a little bit by each eye, a little less than 3 weeks prior to receiving the COVID-19 Vaccine. She clarified she believes she was injected with only 50cc's of a Botox 100mg vial. She said she does not have the Botox NDC, Lot, and Expiration Date from the Botox that was injected into her forehead and eye areas approximately 3 weeks earlier. Patient got the 1st shot of covid vaccine on 05Jan2021. On Monday she had symptoms of bells palsy and wanted clinic trials result for it. Reported her Bell's Palsy symptoms started on Monday, 11Jan2021, and she was formally diagnosed with Bell's Palsy in the right side of her face in the Emergency Room on 12Jan2021 was reported as worsened. She said the doctor told her the Bells Palsy could worsen before it improves. She said the doctors ruled out a stroke and diagnosed her with Bells Palsy. Stated she has tingling in her right arm that comes and goes on 12Jan2021. She doesn't have the right arm tingling all the time. Event details: On Saturday, 09Jan and Sunday 10Jan my right eye began to twitch from time to time. I woke up on Monday very tired and my eyes were swollen and I had bags under my eyes. I felt a little off but went to work. In the middle of the day my right eye began hurting with a burning sensation. I thought I needed to change my contact lenses. The following day, Tuesday 12Jan. I woke up and noticed that I can't fully close my right eye. I felt tired again and my eyes had bags under them. I went to work and felt like not myself. Around 10am, I ate cereal and noticed that I was chewing funny. At 1:30 pm I felt tingling around my right lip and at 4pm I noticed that smile is off and that I was not able to smile fully with my right side. That was when I went to the Emergency Room. She said she was given 3 Prednisone 20mg pills while she was at the hospital yesterday, as well as, a prescription for Prednisone 20mg tablets. She said she is to take 3 Prednisone 20mg tablets per day for 6 days. She clarified once she finishes the Prednisone 20mg prescription, she will have taken 7 days of Prednisone 20mg tablets. She stated the Prednisone 20mg tablets were dispensed in a pharmacy vial, and she does not have the NDC, Lot and Expiration Date. She said she also received a prescription for Valacyclovir 1gm tablets. She said she is to take 1 Valacyclovir 1gm tablet, three times a day, for 7 days. She said the Valacyclovir 1gm tablets are dispensed in a pharmacy bottle, and she doesn't have the Valacyclovir 1gm NDC, Lot and Expiration Date. She said she doesn't want to get the second COVID-19 Vaccine dose now. No Covid prior vaccination. Covid tested post vaccination (Nasal Swab): Yes- Negative. Outcome of reaction/event at the time of last observation was Not Recovered/Not Resolved. Follow-up attempts are completed. No further information is expected.

Employee c/o fullness in throat with difficulty swallowing. No SOB. Given 25 mg of Benadryl IM. Symptoms resolve within a half hour and patient was released to return to work

Tightening of throat, facial swelling, and ear pressure 15 minutes post injection. Treatment given-epi 3mg via epi pen. Outcome- called 911 and medics took over

Pt began to feel tingling around mouth area and throat started feeling thick but not closing. Patient had her own personal Benadryl on hand and administer 50 mg orally to self. Pt was watched for 20 minutes by EMT following administration- she reported her throat continued to feel scratchy. Patient was driven and advised to go to emergency room. hospital was contacted per EMT and informed that patient was in route to hospital following a reaction to COVID-19 vaccine.

Pfizer COVID-19 Vaccine EUA. At 1317 (18 minutes after vaccine administered) Patient observed to have rash to chest and neck. Patient stated she felt "warm in her neck and inner thighs". Rash progressed to ears and face. Patient stated she was having "tingling in the mouth w/progression to her face and eyes. Patient taken to triage area for observation, VS Q 5 mins. Patient noted to have tachycardia PR 103 and elevated BP 178/100 on initial VS. Pulse rate decrease after 5 minutes to 95. BP remained elevated. Patient placed on gurney in recumbent position and water given. Patient given a mirror to view face and patient stated " my face is swollen slightly". Absent selling to lips or tongue. EPI pen 0.3mg/0.3ml auto injector administered at 1339.patient transported to site ED for further evaluation. O2 applied enroute to ED at 4L/min via NC when patient stated she felt a little lightheaded. Patient care transferred to ED and report given.

Patient received Covid19 Pfizer dose 1 vaccination at 1pm. Advised to wait 15 minutes post injection. During waiting period experienced "vision blurring" and "pressure behind eye". Spoke with Dr, monitoring vaccine site. Advised to wait 15 more minutes before leaving. Left vaccination site and started driving home. (Around 1:40pm) Within a few minutes had "extremely sore neck, couldn't turn neck left or right without discomfort" , and felt "thickening of neck." Pain spread from neck to shoulders and mid back. Called Dr, advised to go to return if close or go to nearest ER. Was already miles away from original site so patient went to ER. Received Benadryl. Felt like "giant muscle spasm that wouldn't stop."

Numbness right side of throat, right side of tongue, right side of face and right side of neck. Symptoms still present at the time of release

Sharp pain at bridge of nose that became a tightening across entire face and forehead, rapid heartbeat, nausea, numbness in lips, sinuses pushing on roof of mouth, difficulty swallowing for about 15 minutes about a half hour after taking vaccine. Then about 6 hours same symptoms but without rapid heartbeat, swallowing issues were worse, took Benadryl, after about an hour symptoms lessened and I fell asleep. Next morning roughly 13 hours later would randomly have tightness in face and under chin. Lasted off and on all day.

Reports tongue numbness and strange taste at 4:10PM 415pm Benadryl 25mg and water 422 pm patient reports has no numbness and can't describe the taste but feels good and was able to go home instructions of any more or worsen symptoms to go ER

Approx 15 minutes after receiving the vaccine she started c/o lip abd facial itching. She was given Benadryl 50mg Im to L Deltoid. She said within 5 minutes she was feeling better already. She called a friend that is a nurse practicioner to come and pick her up. no other problems noted

At 1:12 pm, RRT was called and 4 RNs responded to the scene. Stethoscope, pulse ox, and emergency kit brought to scene. Client reports feeling pins and needles in the back of her head. She feels that her tongue and neck are swollen but as assessed, they were not swollen. She also reports feeling tingling in her tongue and neck. She was AAOx4, in no acute distress, no SOB noted. Skin and lip color normal, cap refill <3 seconds. Heart and lung sounds normal. Vitals: BP: 128/80, HR: 90, O2: 99% on RA, RR: 18. She did not report any pain. EMS was not called at this time. It was decided by RRT team that client can be monitored for an additional 30 minutes. RN stayed with client throughout 30-minute monitoring period. RN stated that during monitoring period, client was fine but kept reporting that she felt a lump in her throat. Husband talking with RN revealed that client is not diagnosed with anxiety but does have it. At the end of her 30-minute monitoring period at 1:40 pm, RRT was called again. RN already with client and client reported that she felt tingling everywhere again all over her body and felt like she could not breathe. Additionally, she had that feeling of being embarrassed with the sudden rush of heat throughout her body. Additional RN's arrived to scene at 1:41 pm. Upon assessment, she was not SOB but had rapid breathing associated with anxiousness and nervousness, which she reported. RN noticed client's hands and arms were shaking and client stated it was because she was nervous. Client speaking in full sentences. At this point, RRT RNs decided that client needs 911 assistance which was activated by Fire Chief on site. RNs also assessed that client's tongue was swollen again. Heart and lungs sounds were normal. Vitals at 1:49 pm: HR: 102, BP: 144/70, O2: 95%, RR: 21. At this point, on the basis of the symptoms she was experiencing, RN's decided to administer Benadryl 50 mg IM that was in the emergency kit. When the decision was made, client was asked if it was okay to administer Benadryl IM. She was explained the purpose of Benadryl, the side effects, and risks and benefits. Client consented to receiving Benadryl IM. Benadryl 50 mg IM administered to RA by RN at 13:51. By 13:53, her tongue was not swollen anymore. At 13:58, she was not SOB anymore, talking in full sentences, no acute distress, tingling stopped. By 13:59, the same symptoms of tingling throughout her body, feeling a sudden heat rush throughout her body started again. HR: 65, RR: 21, O2 95%. At 14:01, EMS arrives, truck number 341, vitals stable on their end. At 14:04, client decided to go to RUHS via ambulance. One of the paramedics stated that client's hands were "cold as ice". At 14:07, report was given to paramedics/ambulance and client was in the ambulance. Care assumed by ambulance/paramedics.

This is a 41 y/o woman with who received her second COVID-19 vaccination today. Following this immunization, she appropriately stayed in the waiting area for the 30 minutes. She then got in car and 15 minutes after, she noticed that her tongue was feeling full/swollen and that was experiencing neck swelling. These symptoms persisted and resembled a prior allergic response to Tetracycline and Aleve. Wheezing and breathing difficulty ensued and EMS was activated. On arrival to the emergency department she was found to have wheezing with stridor. A dose of epinephrine was administered and she was monitored in the emergency department with an initial improvement in symptoms. Approximately one hour and 30 minutes after initial epinephrine administration patient reported that she was having continued difficulty swallowing and she was starting to feel a little worse. At this point a second dose of IM epinephrine was administered. The patient was subsequently admitted to inpatient medicine team for further monitoring.

Pt developed swollen lymph nodes in neck and bilateral axilla, fever, body aches, and fever with Tmax 100.4. Also states she had visual hallucinations, "wild" dreams, and seemed "incoherent" when talking with her husband. All symptoms have resolved but still has swollen lymph nodes in neck that wax and wane. Also c/o right side ear pain and right side sore throat x 2 days. Right side ear pain started on 1/24/21, 5 days after vaccine.

heart was racing; increased respiratory rate; tingling in the tongue; full/swollen feeling in the tongue; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received the first dose of BNT162B2 (Lot/batch number and expiry date unknown), intramuscular on12Jan2021 07:30 at single dose in the left arm for COVID-19 immunization. Medical history included PCN allergies from an unknown date. There were no concomitant medications. On 12Jan2021 07:45 about 15 minutes after the injection, the patient felt like heart was racing, increased respiratory rate and tingling in the tongue. Heart rate and respiratory rate quickly returned to normal but the tingling and full/swollen feeling in the tongue continued for about 1.5 hours post injection. The patient did not receive any treatment for the events. The patient did not receive any other vaccines within four weeks prior to the vaccination and did not receive other medications within 2 weeks of vaccination. The vaccine was given in the Hospital. The outcome of the event "heart was racing" and "increased respiratory rate" was recovered on Jan2021 while outcome of the other events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

seeing gray spots room started spinning felt nauseous collapsed on the table; loss of vision; loss of hearing; seeing gray spots room started spinning felt nauseous collapsed on the table; seeing gray spots room started spinning felt nauseous collapsed on the table; seeing gray spots room started spinning felt nauseous collapsed on the table; loss of the onion ability to stand up or walk; loss of the onion ability to stand up or walk; This is a spontaneous report from a contactable other health professional (patient), a 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) at left arm on 14Jan2021 08:30 AM at single dose for covid-19 immunization in a public health facility. Medical history was none. Allergies to medications, food, or other products was No. Patient was not pregnant at the time of vaccination. the patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. the patient received within 2 weeks of vaccination included amphetamine salts 15 mg. Patient woke up in the middle of the night got out of bed walk down a set of stairs started seeing gray spots room started spinning felt nauseous collapsed on the table. Had to call her husband to carry her back up the stairs. she had loss of vision loss of hearing and the onion ability to stand up or walk. He laid her back in bed to pick up his phone and call emergency services within five minutes everything had gone back to normal. adverse event start date was 15Jan2021 03:00 AM. the adverse event result in doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The final outcome of the events was unknown (if patient recovered: Unknown). It was reported as non-serious. Seriousness criteria Results in death, Life threatening, caused/prolonged hospitalization, Disabling/Incapacitating and Congenital anomaly/birth defect were all no.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

weak; hot flashes; cramping; joints hurt; her hands & feet were so cold they hurt (like when holding snow with bare hands); her hands & feet were so cold they hurt (like when holding snow with bare hands); anxiety; dizzy; her body feels weird; sweating; b/p low; throat hurts; tachycardia (119-135); 100.4; chills; body ache; nausea; vomiting; pounding headache; eyes burning; face & neck felt flushed; This is a spontaneous report from a non-contactable nurse (patient). A 41-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular on 11Jan2021 16:00 at a single dose on left arm for COVID-19 immunization. Medical history included asthma, hypoglycemia, vitamin d deficiency, migraines, and allergy to Ilizone (unspecified). The patient was not diagnosed with COVID prior to vaccination. The patient was not pregnant at the time of vaccination. Concomitant medications included loratadine (ALAVERT), phentermine, ibuprofen, and paracetamol (TYLENOL). The patient was administered with first dose of bnt162b2 on 21Dec2020 for COVID-19 immunization (product-COVID 19, brand-Pfizer, lot number-EH9899, administration time-11:45 AM, administrator route-intramuscular, vaccine location-right arm). The patient previously took salbutamol sulfate (VOLMAX) and experienced allergy. No other vaccines in four weeks prior to COVID vaccination. On 11Jan2021 17:00, the patient experienced body temperature of 100.4 (no unit reported), chills, body ache, nausea, vomiting, pounding headache, eyes burning, face and neck felt flushed, tachycardia (her watch kept alarming 119-135), weak, hot flashes, cramping, joints hurt, her hands and & feet were so cold they hurt (like when holding snow with bare hands), anxiety, dizzy, her body feels weird, sweating, b/p (blood pressure) low, and throat hurts. There was no treatment given for the events. The patient has not been tested for COVID post vaccination. The patient is recovering from the events. No follow-up attempts are possible. No further information is expected.

severe left axillary, supraclavicular and anterior cervical lymphadenopathy; left hand numbness/left facial numbness; tongue numbness; This is a spontaneous report from a contactable physician (patient). A 41-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration in left arm on 11Jan2021 at 09:45 at a single dose for COVID-19 immunization in a hospital. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Unknown lot number and expiration) on 21Dec2020 at 09:30 AM in left arm for COVID-19 immunization. Medical history reported as none. The patient has no allergies to medications, food, or other products. There were no concomitant medications. 48hrs post second dose, the patient woke up with severe left axillary, supraclavicular and anterior cervical lymphadenopathy on 13Jan2021 at 06:15 AM. She also woke up with left hand numbness which she initially attributed to the degree of axillary lymphadenopathy bug 2 hours after waking. The patient also experienced left facial and tongue numbness. She went to ER and was evaluated for stroke (all studies normal including labs, CT angio/perfusion and MRI brain) in Jan2021. Facial numbness resolved in about 12 hours, left hand sensory issue is lingering but improving. All lymphadenopathy is ongoing and quite significant. The events resulted in emergency room/department or urgent care. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The patient did not receive treatment for the events. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. The patient did not receive other medications within 2 weeks of vaccination. The patient had not yet recovered from the events severe left axillary, supraclavicular and anterior cervical lymphadenopathy as well as tongue numbness; while recovering from the event left hand numbness/left facial numbness. The events were assessed as non-serious. Information on the lot/batch number has been requested.

Facial and mouth tingle initially. Day later dizzy-room spinning with light exercise. More facial and tongue swelling. Followed by 1 week of swollen glands and tender jaw.

I noticed left ear, left face, and left TMJ pain ~ 48 hours post 2nd- Pfizer vaccine. I noticed headaches and increasing ear/TMJ pain up until today (1/28). The TMJ and ear pain is less today, but it's still difficult to open my mouth. I have tried Tylenol and Ibuprofen to alleviate the discomfort, but the OTC meds to not help.

15-20 minutes post vaccine administration, patient experienced numbness, tingling of cheeks and lips - "very subtle". Lasted one hour then subsided. No return to numbness or tingling as of 1/28/21.

Patient felt flushed then cold and throat felt cold. No SOB nor difficulty breathing. Within ~22 minutes patients symptoms resolved and patient felt back to normal, leaving the clinic without further issues

Shortness of breath with activity; night sweats; right jaw pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248), intramuscular in the right arm on 09Jan2021 at a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history included thyroid cancer. The patient had no known allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. Concomitant medication included paracetamol (TYLENOL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced shortness of breath with activity, night sweats, and right jaw pain on 11Jan2021. Right jaw pain resulted in physician office visit. No treatment was received for the adverse events. Outcome of the events was not recovered. The events were considered non-serious.

40 min after vaccine, noticed that her throat red, hives, flushed, elevated heart rate to 120s-130s. Took Tylenol and Benadryl which improved. Mild lip tingling. Symptoms now resolved. She believes the heart rate was due to "anxiety" After the first dose, only felt flushed.

PATIENT FELT TONGUE SWELLING AND THROAT SWELLING. NEW ONSET HEADACHE. ADMINISTERED DIPHENHYDRAMINE 10ML. PATIENT SENT TO ED.

weird taste (bitter) in her mouth; Lymphadenopathy; significant myalgias; injection site soreness; This is a spontaneous report from a contactable physician (patient). A 41-year-old female patient received the second dose of BNT162B2 via an unspecified route of administration on 11Jan2021 at a single dose as Covid vaccine. Medical history and concomitant medications were not reported. The patient previously had her first dose of BNT162B2 on an unspecified date as Covid vaccine. The patient experienced significant myalgias and injection site soreness, both on 11Jan2021; weird taste (bitter) in her mouth and lymphadenopathy, both on 13Jan2021. The patient received her second Covid vaccine on Monday and was having a weird taste in her mouth (weird taste as bitterness). She has significant myalgia that resolved and injection site pain (injection site pain as soreness) that was resolving. She looked it up and could not find anything. She wanted to know if this was something that they were getting a lot of. The outcome of the event significant myalgias was recovered with sequelae on 13Jan2021 while of the rest of events was recovering. Information on the lot/batch number has been requested.

It started with painful ears and pressure, nausea, sore throat, chills, sweats, general body aches and pain and a little trouble breathing. They started to subside four days after vaccine was administered.

"Pfizer-BioTech COVID-19 Vaccine EUA" Received 1st dose of vaccine in left arm at 10:28 a.m. Drove home and at 4:00 p.m. face, forehead, and neck turned bright red, facial tightness, feeling like face was on fire. Heart rate recorded between 112bpm and 115 bpm and began having shortness of breath. Then began feeling nauseous, eyes were itchy and had a headache. Took 10 ml Benedryl @ 4:40 p.m. and drank some water. 7:00 p.m. still have slight facial and neck redness and headache.

Numbness of lips on 1/28/2021 and then developed numbness of tongue and eye would not close. Saw physician who treated her with steroids, anti-virals and OTC eye drops for lubrication of eye.

At the 8 to 10 minute mark: Could not stop coughing Lips burning and itching At about 20 minute mark: Still coughing Swollen mouth Lips burning and itchy - took Flovent inhaler and drank water About 45 minutes Same and worse , nurse gave me 25 mg of Benadryl After about 20 minutes coughing reduces, Swelling reduces but still itchy in moisture Still swollen at about 30 minutes of the Benadryl and the nurse gave me another dose of Benadryl. Symptoms started to get somewhat better I was very tired from the Benadryl Next day my mouth was still swollen Next day chest was very very tight and took inhaler constantly Third day after vaccine had an asthma attack, hadn?t had an asthma attack since I was in middle school. Dr prescribed prednisone and to take Zyrtec along with my inhaler I cannot return to exercise until 10 days after the start of prednisone

Itching on arms and chest began Jan 30 approximately 4pm. Got progressively worse throughout the night. Hives covered 95% of body, including eyes which began to swell shut. Took 50mg Benadryl with little relief. Went to Urgent Care and was given: 01/31/2021 0836 famotidine (PEPCID) injection 40 mg 40 mg Intravenous 01/31/2021 0836 diphenhydrAMINE (BENADRYL) injection 25 mg 25 mg Intravenous 01/31/2021 0836 methylPREDNISolone sodium succinate (Solu-MEDROL) injection 125 mg 125 mg Intravenous 01/31/2021 0840 EPINEPHrine (EPIPEN) injection 0.3 mg 0.3 mg Intramuscular Raised lesions started to flatten 1.5 hours after medications were administered Dx to home with prescription for Epi Pen, prednisone PO 60mg 1dose/day and instructed to continue taking 50 mg Benadryl q4-6 hours and Pepcid OTC 1 dose per day. Instructed to follow up with PCP in 1 week.

12/18/20: I recieved first dose Covid vaccine, 12/20/20: developed blurry vision, diminished color, altered depth perception, light sensitivity in right eye, 12/21/20: exam by opthalmologist (Dr), 12/23/20: MRI with and without contrast: showed active inflammation on right optic nerve, optic neuritis - referred to neuro opthalmologist, 12/29/20: examined by Dr. (neuro-opthalmologist), confirmed optic neuritis and referred to Dr. (neurologist) for further eval of possible MS, 01/18/21: virtual meeting with Dr., labs ordered. 02/01/21: no treatment to date and I am still experiencing all original symptoms, though have slightly improved since initial onset. Planned follow up with Dr. (neurologist) this week and follow up with Dr. (neuro-ophthalmologist) next week

Patient had a covid vaccine at 9:25am. Please note the patient has no history of anaphylaxis, panic attacks, or heart issues. She started saying her lips were feeling numb and kind of strange and her back hurting. 50mg of benadryl was given at 940am. Patient continued to decline. She complained of chills, chest pain, and n/v. She was visibly shaking. BP was 168/137 HR 99 and oxygen 96%. 911 was called at 9:45am. AMR arrived at 9:55am and took over. Patient was taken to ER.

Patient reported to vaccine clinic to receive second dose of Pfizer Covid vaccine. First dose received on 1/12/2021 without any problems or reaction. Patient reported history of anaphylaxis to shellfish so she was asked to wait 30 minutes post vaccination for observation. Around 15-20 minutes after receiving vaccination, it was noted patient was rubbing her throat. RN at vaccine clinic asked patient if she was ok and she reported she was fine, she thinks it is in her head. RN noted she continued to rub her throat and asked her to describe what it felt like. Patient felt sensation of tickle in her throat and asked for water. Patient also noticed began to itch all over. Patient provided water and 25 mg PO Benadryl. Patient noted it felt like her throat was starting to close and her tongue felt it might be swelling. Epinephrine 0.3 mg IM was administered at 12:07 and patient arrived in ER at 12:08. Patient received another dose of IV benadryl and famotidine and kept for observation. She was discharged home after a couple of hours.

Both times I received the vaccine on the third day I my migraine was triggered and I experienced severe migraines, nausea and vomiting with extreme pain and sensitivity to light and sound. I also experienced severe body pain after both shots. I did not see my physician who I listed but she has notes about my history or migraines. It was suggested on the CDC tracking app to report here too since my reactions were severe.

Client presented for 1st dose of Pfizer Covid Vaccine. Patient's history was reviewed indicating history of anaphylaxis to iodine. 30 minutes after vaccination, client reported she had numbness of her tongue (anterior 1/3), some numbness of her lower cheeks/jaw. No difficulty breathing. BP120/85; HR 80. After a few minutes was reassessed and vitals were unchanged. Client felt anxious. No rashes, no breathing issues but continued anxiety and symptoms of numbness continued. 911 called. EMS assessed and vitals unchanged. Numbness lessened to just tip of tongue. Normal speech. EMS did not transport and father arrived to pick her up at 12:15 pm.

Facial filler swelling in cheeks and lips; Facial filler swelling in cheeks and lips; fever; chills; coughing; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient (also age at vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number Not available/provided to reporter at the time of report completion, dose number: 1), via an unspecified route of administration in left arm on 21Jan2021 09:30 at SINGLE DOSE for covid-19 immunisation. The patient is not pregnant at the time of vaccination. Medical history included prior to vaccination the patient was diagnosed with covid-19 on unspecified date. However, since the vaccination the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products and no other medical history. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. The patient's concomitant medications were not reported. The patient experienced Facial filler swelling in cheeks and lips, fever, chills and coughing on 21Jan2021 at 12:00 AM. No treatment was received for the events. The case was reported to be non-serious (not resulting to death, Caused/prolonged hospitalization, Congenital anomaly/birth defect, Disabling/Incapacitating or Life threatening). The outcome of the events was not recovered. Information on the lot/batch number has been requested.

Patient felt tightness and "tingly" in her throat about 15 minutes after vaccination. Hx of tachycardia after first dose - discussed with PCP who indicated unsure if this was a reaction or not. However, PCP felt pt should go ahead and take the second dose. Pt's baseline HR is around 66. HR taken - 73. Patient said it felt like pins on her tongue. Drank one bottle of water, denied SOB or throat issues. HR monitored for another 30 minutes and returned to baseline. Patient had another bottle of water and tinglyness dissipated. Declined to go to ED for further evaluation, and said she would follow up with PCP if she noticed any further issues.

Within hours after 1st dose, felt foggy, L arm & neck pain & bad headache. Felt better the next morning. 2nd dose, felt foggy, L arm pain & bad headache hours after. Fatigue the same night, had chills, couldn?t sleep and woke up with a temp of 100.3, sinus & ear pressure/pain, congestion & then a runny nose, headache, L arm & neck pain, felt like I was swallowing rocks, sore throat, diarrhea

Got second vaccine on Tuesday feb 2, by Wednesday evening I felt extremely tired and sore muscles. By Thursday/Friday I noticed that it seemed as though the glands in my neck were swollen (slightly affecting my salivary glands especially on left side). My left armpit is very swollen and remains swollen to today. By Friday and into Saturday and currently I developed tinnitus in both ears. My ears feel stuffy, like I went up in an airplane and they need to pop. The tinnitus is really loud, especially at night and has triggered my anxiety. I?m so upset and scared I?ll have tinnitus for life now. I?m an avid bird watcher and I?ve also prided myself on excellent hearing, so I?m taking this hard. Very, VERY, scared.

Patient felt itchy throat and felt like her tongue was tingling about 12 minutes after vaccine administration. Was evaluated in clinic and found to be AAOx3, NAD, nontoxic, no swelling of lips or tongue, lungs CTA with good air entry, regular rate and rhythm, given x1 dose of diphenhydramine and transported to the Emergency Center where she was evaluated again. Found to be in similar condition as above so given an additional 75 mg total of diphenhydramine. Sent home after short observation period.

I immediately felt nauseated and fatigued, but severe reaction occurred at 10 pm. Extreme weakness and tingling on lips and tongue with difficulty breathing. Migraine and body aches not resolved with OTC meds. Lower back pain was notable and prevented me from sleeping. I passed out in the bathroom when trying to get Tylenol.

Head and nasal congestion; Head and nasal congestion; ear ache; body aches; fatigue; sore arm; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283), via an unspecified route of administration on 22Jan2021,16:30 at SINGLE DOSE (first dose, left arm) for COVID-19 immunization. Medical history included allergies: Latex from an unspecified date. Patient did not have COVID-19 prior vaccination. Patient is not pregnant. No other vaccine in four weeks. The patient's concomitant medications were not reported. The patient experienced head and nasal congestion, ear ache, body aches, fatigue and, sore arm all on 23Jan2021 01:00. No treatment was given. Patient was not tested for COVID-19 post vaccination. Outcome of the events was recovering.

States shot felt weird going in to arm. Felt "thick". Ears began to ring and felt light headed 1625 BP 104/? O2 sat unable to obtain due to cold periphery 1630 BP 118/? O2 sat 97% cold periphery 1640 BP 137/86 HR 76 O2 sat 98% RR 16 lungs clear 1645 BP 127/75 HR 70 O2 sat 100% RR 16 1650 BP 130/79 HR 70 O2 sat 100% RR 18 lungs clear After 40 minutes stated felt better provided snack bar, apple and water was able to leave area at a baseline level.

Light headedness; scratchy voice; itchy eyes and throat; itchy eyes and throat; pink and hot swollen circular hive/welt underneath injection site on left arm; pink and hot swollen circular hive/welt underneath injection site on left arm; This is a spontaneous report from a non-contactable other healthcare professional, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 20Jan2021 at 07:30 (at the age of 41 years old) as a single dose in the left arm for COVID-19 vaccination. Medical history included seasonal allergies from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination, but did receive the first dose of BNT162B2, on 31Dec2020 in the left arm. On 21Jan2021 at 09:30, the patient experienced light headedness, scratchy voice, itchy eyes and throat, pink and hot swollen circular hive/welt underneath injection site on left arm. The patient did not receive treatment for the events. The clinical outcome of light headedness, scratchy voice, itchy eyes and throat, pink and hot swollen circular hive/welt underneath injection site on left arm was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

This 41 yo female received her first Pfizer COVID vaccine (Lot EL1284) on 1/7/2021. She reports being in good health, had no illness exposures (does work in hospital with children), and had no recent travel. She reports following her Covid vaccination, she had a sore arm at vaccine site for 4-5 days with no other issues. On 1/31 (day24) while putting on lipstick to take a selfie to send to her friend she noticed the right side of her lower face (lip area) felt "weird"- tingled and the corner of her mouth would not smile symmetrically with left. Her friend commented something was off with this picture. The next day this droop worsened with loss of facial lines/wrinkles on right (nasolabial fold), had tingling/numbness to lips and corner of mouth and inability to smile on right. This prompted her husband to bring her to the ER on 2/1/2021. She denied any fever, headache, weakness to arms/legs, no SOB/CP, dysphagia or speech issues or trauma. ER providers exam noted normal CN evaluation but documented mild right sided decrease in nasolabial fold vs left and loss of taste to anterior right tongue. She had no involvement of eye or forehead. She was diagnosed with early Bell's Palsy and treated with oral steroids and anti-virals. AS of 2/10/2021 with use of medications, she advised her facial weakness/droop had resolved but still has tingling. Her smile is symmetrical at this time. No c/o on loss of taste. Has diagnosis of Bell's Palsy. IHD case 9967.

At 3pm the day I received the shot I was woken up from a nap with intense tooth pain. My top, front 4 teeth were in so much pain I cried. I took 100mg of Tylenol and the pain lessened in about 2 hours. At approximately 10am on 2/5/21, I became clammy with shivers yet I was feeling over heated. My temperature was 99.3 degrees. I did not take any medicine but instead took a nap. When I woke up, my temperature felt normal. I did feel dizzy until around 4:3pm that same day. I still get headaches in the front of my forehead since 2/5/21.

I suddenly developed Tinnitus after receiving Pfizer COVID-19 vaccine dose #2. It's so loud, I have difficulty concentrating and sleeping. I happened to tell someone else about this and she reported that her Tinnitus was significantly worse following dose #2 of Pfizer vaccine.

Hard to breath right chest but took inhaler and was better. Hives took 50 mg of Benadryl at sight then after one hour went to primary Dr to get checked out. Was told to take 25-50 mg of Benadryl every two hours and Pepcid 20 mg one tablet 2 time daily, itchy burning eyes use eye drops, come and go since 01/29/2021. I get really tired and upset stomach also 2/09/2021

About 5 hours after the injection I got a strange sensation in my gums/teeth/jaw/pallet. Within about an hour of one tooth hurting, all of my upper molars and jaw hurt and had a nerve sensation. It was like the roots of all the molars were irritated. The nerve sensation also felt like it was in the upper jaw/face area. My entire pallet became irritated. This lasted for about two hours and then went away completely.

Information reported by individual involved as follows. AFTER 2ND VACCINE OF PFIZER I HAD SEVERE MUSCLE ACHES AND FEVER ABOUT 12 HOURS POST VACCINE WHICH IS EXPECTED DIAGNOSED MILD CASE OF BELLS PALSY. LEFT SIDED FACIAL NUMBNESS TO CHEEK, TONGUE, MOUTH GUMS, INCREASED SNORING, THESE SYMPTOMS WERE NOTED SHORTLY AFTER VACCINE #2. I DID NOT PUT IT TOGETHER AT THE TIME THAT I WAS HAVING REACTION TO THE VACCINE ONLY AFTER DOING SOME RESEARCH ON WHAT COULD BE LEADING TO LEFT SIDED TONGUE NUMBNESS DID I REALIZE I COULD BE HAVING BELLS PALSY A REACTION TO THE VACCINE. WENT TO EMPLOYEE HEALTH ON 2/1/21 AND THEY NOTED POSTIVE MILD CASE OF BELLS PALSY. AFFECTED IS LEFT SIDE OF FACE, GUMS CHEEK TONGUE AND SLIGHT DROOP

7 minutes after vaccine, I felt my heart pounding heavily and checked my iwatch. It indicated that my Heart rate went from 88 to 141 in the past 5 minutes while sitting. I then felt flushing throughout my body. I had the sensation of tingling on my face and lips and told the present employees that I felt weird. They retrieved the doc, who then took my pulse ox - registered at 96/97. Then they took my blood pressure and it was 180/100 (I typically have low blood pressure 98/60). I started to feel disequalibrium and nauseous and the doc to be back to a room. She administered a dose of IM EPI and IM benedryl and called EMS. My symptoms persisted and the doc told the EMS workers I had urticaria on my face during her case presentation. I was transported to the ED, where I was monitored. My symtoms had reduced following epi and benedryl but returned when I was in the ED. The doctor administered pepcid and solu-medrol and zofran. They also conducted and EKG- reportedly normal. These medications helped control my symptoms and my BP had returned to normal (120/70) following meds. discharged on a tapering dose of steriod and zofran prn.

Patient sat in our waiting area for 15 minutes and no obvious signs/symptoms of reaction to vaccine were reported or noted. Per patient, after she left our office, at 12:20 pm, she experienced "chest tightness, racing heart rate, could not feel her tongue and throat was tight." She went home, took Benadryl (25 mg) and she was "ok" after that - symptoms subsided. She followed up with her primary care provider, who advised her not to receive the second vaccination due to this adverse reaction. Patient informed our office, of her adverse reaction on 2/15/21 - we are reporting today because she was able to provide more information regarding the event.

41 y old female received first dose of her COVID vaccination, she started feeling dizziness and mild sensation of dry / inflamed throat. she denied any sob, wheezing, chest pain, rash, or any other sx. denies pervious allergies. PE: lungs ; CTA bil , heart; RRR. neuro: alert and oriented. responding. 08;15: BP: 146/88, HR: 72 O2:100% 08:38: BP: 152/86 HR: 67 Sats: 100% - pt was feeling much better and denied any sx Pt was monitored for 30 mins and reported resolution of sx before she left the clinic. she was able to drink apple juice without any issues.

Dose 1: About 5 minutes after injection slight dizziness and ear felt stopped up. Later that night chest was flushed. Flushing lasted about 2 hours Dose 2: Due to flushing with last infusion, nurse told me to wait there 30 minutes after infusion. About five minutes after starting getting a headache and left ear was stopped up. Was told to take Benedryl if rash(flushing) came back with this infusion and to report symptoms to CDC. Headache and nausea felt till next day. Felt sick and headache riding in car. At 0130 am on 2/18/21 was awoken by pain under right arm. Very mild swelling noted but very sore to put arm down and tender to touch. Underarm still sore as of today Feb 20, 2021. Second day joint pain in shoulders, elbows, fingers, and knees. Joint pain improved but still there as of Feb 20, 2021. Ibuprofen and Tylenol did not help headache or joint pain. Third day headache off and on with nausea once, right hip pain. Feb 20, 2021 Fourth day underarm and joint pain improving , nasal and ear congestion

got Shot about 8:30; immediately after getting the shot, I had the same feeling as my breath being taken away and the taste (just like after getting an IV cleaned with saline). Nurses told me to sit up front to be observed and waited 30 minutes. After the 30 minutes, I began getting very warm (went outside to get fresh air); went to vehicle, took mask off face, was still feeling very hot, Face was bright red, lips were very red (looked like I had on makeup and I didn't have any on). Took 4 children's Benadryl (dissolvable). Went back to work. redness started to go away. Throughout the morning, I continued having the feeling of breath being taken away and the taste. It wasn't as bad, so I didn't worry. My lips were not too swollen, face was still swollen. I have had MANY reactions to food allergies and didn't wanna "cause" a scene. By 1:30, I was in a meeting trying to talk and my tongue started to feel thick and it was harder to talk. I took 2 adult Benadryl's and tried to work some more to keep my mind off of the reaction. I ended up being very tired and laid down. I slept till about 5pm and seemed okay after. Nothing else was done. My muscle was sore, no other symptoms.

itchiness along left side, pain in neck on left side, itchiness of the lips, minor swelling in tongue and throat

Pfizer shot #1: She received the 1st COVID vaccine Pfizer on January 24th at 7:00 p.m.. The following day she noted a low-grade fever. On January 26 she noted edema of her eyes and lips associated with facial redness and itching that she treated with Benadryl intermittently for the past 2.5 weeks. She was seen in follow-up by her dermatologist who suspected an inflammatory reaction and prescribed anti-itch facial cream. She was also seen by her primary care who suspected angioedema and prescribed her an EpiPen which she has not needed to use. Pfizer shot #2: 2nd shot delayed due to snow. Above sx resolved before shot #2. She had her 2nd COVID injection February 20 at 3:50 p.m. About 1.5-2 hours later she noted onset of itching to her eyes and nipples along with itching of the skin in the locations of her usual eczema. She noted that her lips and eyes were a little puffy but less severe swelling to the eyes and lips than the 1st injection. She took 2 Benadryl shortly after onset of these symptoms. This seemed to lessen symptoms about 50%. Later she noticed that her voice sounded raspy and hoarse and she had a sensation of swelling to her tongue and throat but she was able to swallow. Her throat felt scratchy. She denies having lightheadedness, urticaria or GI symptoms. She went to the ED and was treated with benadryl, solumedrol and pepcid, monitored for a few hours and then discharged on 60 mg prednisone X 3 days and advised to continue benadryl 50 mg Q6h. She takes zyrtec 10 mg BID for seasonal/perennial allergies. Allergy history: She has a history of both idiopathic urticaria in early childhood and idiopathic angioedema in her early 20's. States she had extensive testing but the cause was never exposed. Took high dose prednisone for 4-5 months, angioedema resolved spontaneously and then flared again a few months later. Finally resolved with n additional 3 months of prednisone. She has both seasonal (feb-may) and perennial allergies to cat and dust, asthma and allergy to ampicillin--rash in childhood, and humira--fevers.

About 5 minutes after receiving the shot, I experienced a tickle in my mouth, and then shooting burning waves down both sides of my spine (just to the left and right) starting in my neck and settling in my groin. It felt like intense burning and buzzing waves going down from my neck. The paramedics came, said there were no signs of anaphylaxis, and took me to ER. They gave me benedryl and pepcid in an IV, I felt drowsy. The waves eventually subsided and were gone around the time of the benedryl (not sure if before or after).

Migraine, head pressure, ringing ears, dizziness. Now I have Vestibular migraines, I am off balance. Still have dizziness, and head pressure. Headache comes and goes. First 2 days I also had inside vibration and energy zap in my whole body.

Within 3 minutes, had facial tingling and numbness. Tongue felt ?thick? with it 30 minutes. Received 50 ml injection at that time. All symptoms resolved within 5 hours.

Day of vaccine 2/20 to following day experienced injection site pain but no other symptoms. The night of 2/25 (almost 6 days later) experienced flu like symptoms - chills, shaking due to cold, fever, thirst, joint and body aches, light headedness, fatigue. Morning of 2/26 chills and fever had subsided, had 8/10 severity headache that gradually decreased throughout the day. Body aches gradually subsided throughout the day and all symptoms were resolved by 6pm on 2/26. I had very similar symptoms after my first dose as well - initial injection 1/29 at 12:30pm, flu like symptoms began early morning of 2/1 that lasted about 15 hours.

Numbness in tongue and lips six hours after taking the vaccine. I took a Benadryl and the symptoms subsided after 60 minutes. I also experienced dizziness and weakness right after taking the vaccine, which lasted for 24 hours. Other symptoms include tiredness, headache, muscle pain, chills, low-grade fever, and nausea, which have lasted for 24 hours and continue now.

MRI showing inflammatory lesion of the Pons/Single lesion appearing inflammatory in nature found in the pons at origin of cranial nerve 6; single lesion appearing inflammatory in nature found in the Pons at origin of Cranial Nerve 6; Development of double vision/double vision with right gaze and head turning; mild chills; headache; significant diarrhea; vision noted to be off; This is a spontaneous report from a contactable other health care professional, the patient. A 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL1283), via an unspecified route of administration on 14Jan2021 at 01:15 (at the age of 41-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included spontaneous coronary artery dissection with stenting (reported as "five years ago") and complex migraines from an unspecified date. The patient is allergic to Tramadol, Codeine and Novocaine. The patient's historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EH9899) on 23Dec2020 at 01:15 AM as a single dose in the left arm for COVID-19 immunization.The patient was not pregnant at the time of vaccination. The vaccination was administered in a hospital. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included diltiazem (MANUFACTURER UNKNOWN), acetylsalicylic acid (ASPIRIN).The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient reported the development of double vision on 25Jan2021 at 06:00. She was hospitalized and remained hospitalized for three days. She reports having had an MRI (date not specified) which showed an inflammatory lesion of the Pons. She further described the events as follows: Initially mild chills and headache "the day after" developing into significant diarrhea for four days and on and off diarrhea for several weeks. One week after vaccine vision noted to be off but no official work up developing into double vision with right gaze and head turning three weeks after vaccine. She also stated that there was a single lesion appearing inflammatory in nature found in the Pons at origin of Cranial Nerve 6. Treatment received included Solumedrol and Pepcid infusion. Lab data included an MRI on an unspecified date which showed inflammatory lesion of the Pons and COVD-19 testing as follows: SARS-CoV-2 Nasal Swab PCR test on 20Jan2021 and on 11Feb2021 both of which were negative. The clinical outcomes of brain inflammation, double vision, chills, headache, diarrhea, vision decreased and cranial nerve disorder were reported as recovering. No follow-up attempts are possible. No further information expected.; Sender's Comments: Based on vaccine-event chronological association, a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Friday at 4pm I experience severe unquenchable thirst and mild injection site soreness. Saturday morning was restless sleep and headache with severe joint pain and thirst. All Saturday same. Skin hurt to touch and knees and finger knuckles hurt to touch. Vomiting. Throbbing injection arm pain and the urge to constantly stretch all limbs. Sunday all subsided except the throbbing arm pain. Sunday evening at 8 pm throbbing arm worse and headache. Monday 3am restless sleep and miserable comfortableness. Throbbing arm and restless painful shockwaves through entire body. Skin severely hurt to touch. Went to the ER. Treated with Atavan and prescription Motrin.

pt stated that soon after she received the covid vax she felt like the back of her neck was on fire. She was flushed and itching. When she scratched her skin it would turn into a hive. Her eyes were swollen and looked bruised. She tried to eat a cracker but was not able to swallow. She became nauseous and winded. She went to the ER. Her entire back was red and inflamed. They administered Benadryl. Pt was released and to FU w/ PCP. That night she had some chills and fatigue. When she got up today 3/2/2021 she was super itchy, not able to swallow food and had diarrhea for two hours . She had a virtual appt w/ doctor and was referred to see her PCP. She made an appt w/ PCP. Her Dr. wrote her a RX for prednisone. Told her to take Benadryl as well and to stay off work for a couple of days.

Pfizer-BioNTech COVID-19 Vaccine EUA: The patient reported to have received 2nd Pfizer COVID-19 vaccine on 2/19/21. Unknown where the patient got their vaccine administered. Immediately afterwards, the patient developed hives, cough, and lightheadedness and was sent to Hospital. They were treated with steroids and diphenhydramine. Their symptoms resolved and they were discharged. On 2/20/21 patient came to emergency room in the morning with allergic reaction. They woke up in the morning with hives, swelling in face, and feeling of thickness in throat and shortness of breath. They were given dexamethasone, diphenhydramine, and famotidine. Their symptoms resolved and they were discharged. While at home the patient developed hives and took diphenhydramine. They had tingling and a rash over their face. On 2/20/21 the patient returned to the emergency room in the evening with a rash. The symptoms were pain and burning. They also complained of abdominal cramping, mild nausea, and left sided chest pain. Their symptoms improved and they were discharged. On 2/22/1 the patient returned to the emergency and was subsequently hospitalized. They presented with face swelling, general pruritus, and hives. She reported chest tightness and paresthesia involving her lips. Admitted on 2/22/21 to 2/25/21. She was given diphenhydramine, famotidine, and hydrocortisone.

Patient received her second covid 19 vaccine on the 18th of February - about four hours after she developed some soreness, fatigue and had a hard time moving her arm. Continued for a couple of days. Sunday 2/21 patient woke up without taste and her tongue was numb. That evening she began having some neck pain, below her ear, she massaged and didn't help all that well. At around 3 am that night, the pain was entirely on the right side of her neck and face, she took ibuprofen which mildly helped at night it was the entire neck. Monday 2/22 patient massaged area and it helped a little. She continued to have pain Tuesday 2/23 - Around 9am that morning patient noticed right sided facial drooping and her tongue was not working properly. She also noticed that her eye would not respond like her left eye. It was sluggish. When she went to brush her teeth, she noticed that the water would not stay in her mouth and it came out. At around 7pm that evening she went to the emergency room

face started to feel "hot and on fire"; face and neck turned bright red; face started to feel really tight; Heart Rate then was elevated to 115 bpm; shortness of breath; itchy eyes; headache; nausea; Arm still felt sore; fatigued; At site of injection there was a warm sensation; metallic taste in my mouth; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262) solution for injection, intramuscular at left arm on 29Jan2021 at 10:30 AM at single dose for COVID-19 immunization. Medical history included asthma. The patient has no known allergies. The patient's concomitant medications were not reported. The patient was not pregnant and has no other vaccines in four weeks. She will have a birth control in two weeks. It was unknown if the patient has COVID prior to vaccination. She was not tested with COVID post vaccination. The patient was given COVID-19 vaccine at a hospital. When she initially received the vaccine on 29Jan2021, the site of injection had a warm sensation which resolved within a minute. Then on the ride home, she had a metallic taste in her mouth. While at home around 4:00 PM, her face started to feel hot and on fire and then her face and neck turned bright red. Her face started to feel really tight and hot. Heart rate was then elevated to 115 bpm. She then started having shortness of breath, itchy eyes, headache and nausea. The patient sat down and took 10 mL of BENEDRYL (as reported) at 4:30 PM or 4:40 PM. Between 5:00 PM and 7:00 PM, her face and neck were still slightly red. Her arm felt sore and she was fatigued. She again took 10 mL of BENEDRYL at 7:30 PM. She woke up on 30Jan2021 and still felt fatigued and the back of arm (tricep area) was very sore. The patient also took paracetamol (TYLENOL) 600 mg. The outcome of the event vaccination site warmth was recovered with sequel on 29Jan2021 and recovered with sequel on Jan2021 for all other events.

On 2/28/21 I began feeling numbness on the right side of my tongue and mouth. 3/1/21 numbness/weakness began spreading to my right cheek and right side of lips. By 3/2/21 the numbness weakness covered the entire right side of my face and caused mouth and eye droop. Went to the ER and was diagnosed with Bell?s Palsy.

My lips got swollen after 24 hour of vaccine, took Benadryl but lips are still swollen after takin it.

Tongue swelling and palpitations and difficulty with speech and swallowing, and throat tightness. onset within 30 minutes of vaccines. taken to Urgent care, received epinephrine injection, then transferred by ambulance to Hospital ER. given IV diphenhydramine and IV decadron. chest pain. normal ECG and troponin. They did not check tryptase.

Reports symptoms began 6pm , 1 hour after receiving vaccination, headache and feeling bumps on her tongue and roof of mouth, taste was off. on 3/3/21 midnight was awakened from sleep from pain in all of her joints, back and neck. Experienced dizziness and fatique in the morning.

With having MS, I have severe anxiety and I was anxious before going in- numbness and tingling in my legs and tingling on my tongue. Took Benadryl - tongue tingling went away and the legs tingling and numbness was the same and started getting worse - they monitored my vitals and everything looked good and numbness remained. I had a driver and they allowed me to leave due to the Benadryl _ just took that one dose of Benadryl (didn't take anymore after that) and then the numbness in my legs remained for about two and a half weeks. I used a cane for two days. I had a fever and chills that first night, body aches and injection site pain and severe fatigue and those symptoms lasted one day except fatigue was for three days. The day after the shot was the worse of the symptoms. They followed up with me that evening and they followed up with me at work. I had the next dose - February 4, 2021 and experienced everything except the numbness in the tongue. Informal doctor visit because I work there.

Pt developed a few hive-like lesions on her legs on 1/28/2021, 2 days following first COVID vaccination. Over the next 2 days developed more. Each lasted less than 24 hrs, but some lesions were always present. No other symptoms. Allegra resolved hives. On 1/17/2021 after second COVID vaccination, she developed headache, body aches, and low grade fever lasting 1 day. Three days later, hives returned, worse than with first vaccination. Allegra resumed up to qid. On 2/23/2021 developed severe chest pain, waxed and waned through night, resolved by next morning. Was hive-free between 2/24 and 2/28 when the hives recurred. Has had two bouts of lip swelling. Hives persist, despite antihistamine use, to the present.

After 10 minutes, patient reported metal taste in mouth and feeling faint. She also felt tingling in her arms and lips. She struggled to get up. Her breathing seemed fine but neck was red. She laid on floor with legs elevated until her dizziness subsided. She originally said she felt better but then dizziness returned. Called 911 and had Epi-pen ready. She was breathing fine when paramedics arrived. Her husband later called at 7:45pm and reported she was feeling fine. He said the emergency room gave her a steroid, anti-histamine, and pepcid. She is not going to receive the second covid shot. Her husband later stated she got a full body rash when she had covid. I also advised them to register on the v-safe site.

Flushing feeling in face 7 minutes after vaccine was administered, then over the next 7-8 minutes there was an increasing feeling of throat tightness. It started on the right side of throat, then the left a few minutes later. Eventually a feeling of pressure behind eardrums and a little trouble swallowing. Epi was given approximately 20 minutes after vaccine was administered, then a dose of Benadryl. Paramedics were called, transported to ED for observation for 4 hours. Symptom of tightness in throat improved within minutes of Epi, returned after a few hours with less severity. That feeling took a few days to completely subside.

Progress Notes (Nurse Practitioner) Pt called to follow up s/p covid-19 vaccine done on 02/24/21. She reports she took a nap yesterday after getting home and felt better afterwards. Today she feels well. Denies any other questions or concerns. She is appreciative of the phone call. Progress Notes at 2/28/2021 7:34 AM Expand AllCollapse All VACCINE CLINIC 2/24/2021 Subjective Patient is a 41 y.o. female who was seen at SVH COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience lightheadedness, headache, nausea, tingling lips and a metallic taste in her mouth. She denied rash, difficulty breathing, difficulty swallowing, throat tightness, facial swelling and lip swelling. She does mention having a history of anxiety and did take her duloxetine and Wellbutrin today. Denies use of her Ativan recently. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to rapid progression of symptoms, respiratory distress, tongue swelling and vomiting. ALLERGY REVIEW OF SYSTEMS: Patient complains of dizziness and headaches Patient denies chills, facial swelling, chest tightness, shortness of breath and wheezing +nausea and metallic taste in mouth: Previous Reactions: Denies Objective Vitals Vitals: 02/24/21 1427 02/24/21 1434 BP: 126/70 112/68 Pulse: 81 80 SpO2: 99% 96% Physical Exam Constitutional: Appearance: Normal appearance. HENT: Head: Normocephalic and atraumatic. Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. No posterior oropharyngeal erythema. Comments: No swelling or lips or tongue. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing or rales. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Assessment/Plan Treatment included: Tylenol and water Follow up response to treatment: good. She noted some lightheadedness prior to discharge but other symptoms were improved. I walked patient around the bay area and she was feeling okay. Her vitals were stable. Pt was escorted out of the facility. Patient discharge: Stable to go home and follow up with PCP. Electronically Signed 2/24/2021 2:43 PM

Metallic taste in the mouth, tingling of the mouth, nausea. Refused evaluation from EMS, cleared by medic on site.

1/9/21: second dose of vaccine administered at day 12 body chills, aches by 11pm 1/10/21: body aches, low grade fever, woke up early morning (6 or 7am) with nausea, weakness- husband had to help me to bed, headach by 4pm fever was getting higher, body aches and chills worsen. Called Telehealth for support and was advised to go to ER At ER arrived with high fever, full rigor, bones felt like they were breaking one by one so bad body aches, chills 1/12/21: First day of cognitive issues - sever fatigue, could not comprehend anything, could not work or do school 1/17/21: Realized the cognitive issues were bad and needed to see DR, dizziness, audio distorted, couldn't follow directions 1/18/21: First Dr apt at medical center Currently still in Dr's care 2/23/21: First Nuro apt with specialist

o Complaint The patient is a 41 year(s) old Female complaining of allergic reaction, nausea. o Chief Complaint Quote Patient complained of allergic reaction that started about 45 mins ago. She got her 1st dose of Pfizer Covid vaccine yesterday morning. She complained of rash all over the body, swelling on the hands and face including eyes and lips. She denied chest pain, abdominal pain, fever, cough, vomiting and difficulty breathing. She complained of nausea that started 5 mins ago. She has not taken any meds yet for her symptoms. o Time Seen 02-18-2021 01:20 o Historian patient ADDITIONAL HPI: o Additional HPI Pt here with concerns of allergic reaction. Pt fell asleep on the couch approx 2200. She awoke 2 hours later with itching of her hands. Over the next hour she developed a full body rash, itching, and swelling of face. No wheezing, no difficulty swallowing. Upon arrival to ED pt started to feel nauseated. Pt had first dose of COVID vaccine approx 16 hours prior to onset of sxs. No h/o allergic reactions, no h/o asthma. Emergency Department Course and Clinical Decision Making: Patient presents with urticaria and swelling to her face eyes and lips. Shortly upon being roomed she started to feel very nauseated and started vomiting. No stridor or wheezing, no immediate airway compromise but given both cutaneous and GI symptoms, significant concern for anaphylaxis. Patient was immediately given epinephrine intramuscularly, 0.3 mg. An IV was placed and she was given Solu-Medrol, Benadryl, Pepcid, and Zofran. Patient's urticaria and swelling started to nearly immediately improved after the epinephrine. She is feeling much better though slightly anxious. To be reaction from the Pfizer vaccine, no other obvious triggers, patient has no history of allergic reactions or other sensitivities. We will observe in the emergency department in a monitored setting for several hours to assure no rebound symptoms, patient updated on plan. 0500 Pt has been resting. Urticaria resolved, swelling to face resolved. Discussed with pt reporting reaction to CDC, info provided. Also discussed the second dose of vaccine, recommended reaching out to Epi response team or PCP to get recommendations. Will give short course of prednisone, 4 days, Benadryl as needed, ED return precautions discussed, will dc home.

At approximately 10 hours after receiving my second injection of the Covid19 vaccine, I started noticing nausea, headache and a neck ache. Within 5 minutes of these symptoms, my tongue felt swollen and my speech was slowed and slurred. Within ten minutes of these symptoms occurring, my nausea went away as well as my swollen tongue and speech problems. The neck ache and headache progressed into a migraine. I took Tylenol and went to sleep. I woke four hours later with abdominal pain, nausea, head ache and neck ache as well as pain at the injection site. Again I took Tylenol. I experienced fatigue, migraine, neck and back ache, night sweats and axillary adenopathy over the next 5 days. Today is day 6 and I haven't gone a day without neck pain and headache yet. It usually occurs in the afternoon. I continue to take Tylenol and it feels better.

Flushing - entire body; like when you receive an injection of contrast for a CT Scan Burning - Eyes, face, abdomen Nauseous Pressure in head/face/ears Throat discomfort Headache Overall sick feeling Over the next couple days, my lips have broken out. I have some small mouth/tongue sores. Feeling of a cold coming on. Sinus pressure. Throat discomfort, congestion. Sneezing. Eyes burning. Face burning. Itchy patches on scalp. Face breaking out.

I was 32 minutes past receiving the vaccine when my face felt hot. I looked in the mirror and saw that it was. After about thirty more seconds I had trouble breathing and eventually could barely breathe. My face was puffy and my eyes started to close. I received IV Benadryl and two other medications which I can't remember.

Day of: fatigue, sob, weakness, coughing tasting blood, runny nose, watery eyes, pain at injection site, fever, chills, rash around injection site, down arm ans up shoulder and neck Day after and progression: muscle weakness to the point of falling down and inability to hold onto items, SOB, fatigue, blurred vision, ringing in ears, dizziness. Pain, numbness, tingling throughout body. Cough tasting blood, flank pain, intermittent urinary incontinence and increase urination at night, nightmares, anxiety, depression. Today: SOB, cough tasing blood, extreme fatigue, dizziness, tinnitus, nightmares, anxiety, depression. 03/02/21 New onset diagnosis: Severe Asthma I have not been able to work since 01/08/2021

She received the vaccine at 0930 and had itching her lips became numb shortly after starting around 1200. She developed hives around her entire body on her left jaw, face, arms, and rack. Rash resolved within 24 hours with a lot of Benadryl.

ITCHING ALL OVER, SCRATCHY THROAT, ANAPHYLAXIS PT PREMEDICATED WITH BENADRYL 50MG PO AT HOME PRIOR TO COMMING FOR SECOND VACCINATION AT 1125 12:57 PT STATES S/S OF ANAPHYLACTIC REACTION, SCRATCHY THROAT, TONGUE SWELLING, HIVES, ITCHING VS TAKEN: HR 120,RR 20,BP 150/78, SPO2 100% RA 1258: EPI PEN GIVEN X 1 IM TO LEFT VASTUS LATERALIS, PT TOLERATED WELL. 1259: SQUAD AND ER NOTIFIED FOR NEED OF TRANSPORT TO CPH. 1301:DEXAMETHASONE10 MG IM IN RT LETOID GIVEN X 1, PT TOLERATED WELL. 1305: 20 GUAGE SL PLACED TO RT WRIST. PT TOLERATED WELL. 1315: REPEAT VS TAKEN AND STABLE HR 95, RR 20, BP 140/74, SPO2 100% RA. 1315 RESCUE ARRIVED AND TRANSFERED TO CPH

FEVER, MUSCLE PAIN, TIREDNESS, HEADACHE, SWELLING OF GANGLIA UNDER ARM AND NECK, SENSATION ON THE HANDS AND LIPS WITH LIKE PADDING AND TINGLING. PAIN IN THE INJECTION SITE.

The day after the vaccine, my top lip started to swell, burn a little and slightly red. I have had Juvederm lip injections for almost 2 years but had recently gotten a touch up on only my top lip last November of 2020. Bottom lip is fine. Consulted with my doctor. Took Benadryl and was prescribed Claritin and steroids.

1124 PFIZER COVID VAC. GIVEN, 1133 C/O FEELING DIZZY. THEN C/O FEELING NAUSEATED WITH DRY HEAVES, PRESSURE IN RT. EAR AND HEADACHE: 1145. 1150 LOWERED TO THE GROUND, STATING SHE COULD NOT BREATHE. EMS CALLED. EPI VIA IM (PEN) ATTEMPTED X3, 3RD DOSE SUCCESSFUL. EMS ARRIVED SHORTLY AFTERWARDS.

Sensation of tongue swelling during observation-about 15 minutes after vaccine, Medical Emergency team called and arrived less than 10 minutes after call, they assessed and brought pt to ED. Pt's vitals were recorded & stable and information sheet given to ED team. Copy scanned into pt's chart.

A day after the second dose, vision in my right eye was impacted. It progressively got worse. I saw an eye doctor for an emergency visit on Saturday, 3/13. He did a full exam with dilation, and suspects it is an optic neuritis. Today, I had a visual field test, but I am unaware of the results yet. There has been no improvement in my vision since Saturday when I saw the doctor.

Patient received her covid vaccine at 9:50am. She was in the observation area. She stated she couldn't breathe at 9:55am. She showed no signs of any breathing difficulty. Patient reported a past history of anaphylaxis to bee stings. At 9:57am 50mg of Benadryl was given. 9:58 am she reported she was sweaty, had blurred vision, and was hot. At 10:05, patient said she started to feel better. We asked that she wait the full 30 minutes. By 10:20am, she was feeling fine and the symptoms had resolved.

I had dizziness and a headache that jumped around my head within 20 minutes of the shot. About two hours in it felt like my tongue was increasingly getting heavier and heavier for around a 10 minutes timeframe. It then stopped but for two days it felt like I had burnt my tastebuds. Starting two days ago I have developed a red rash on my arms that burns at times and seems to come and go.

10:54 Throat thick, report feeling "funny"/ strange. BP 110/60 10:57 EPI administered, BP 110/80 Throat feels better. Shaky. 11:02 Transported

25 minutes after vaccine shot: throat started to get itchy 30 minutes after vaccine shot: roof of mouth and tongue started to get itchy - went to see nurse : took 50mg Benadryl 40 minutes after vaccine shot: difficulty swallowing: need to clear throat 50 minutes after vaccine shot: nurse suggested taking my EpiPen but I was still able to breathe (all other symptoms were still very present Approximately 25-30 minutes after taking Benadryl symptoms began to subside. No EpiPen was administered. Approximately 95 minutes after vaccine shot: symptoms were reduced enough to go home.

Petechiae (red dots that didn't blanche) all over arms, legs, chest. Racing heart rate, flush face, red eyes, red web like moving up and down the arms and legs, injection site rash.

Red eyes, painful and burning . Went to the ER and then was sent to ophthalmology and was diagnosed with keratoconjunctivitis. The doctor said she has seen this in patients that receive the Covid shot.

I took a bite of an apple around 2 pm the day of the injection and the roof of my mouth immediately blistered up. The glands at the back of my tongue were inflamed, my epiglottis hurt and my esophagus hurt the whole way down to my stomach in my chest. My inner ears felt pressure and throbbed. By that night my whole tongue hurt and I couldn't touch anything to it. This reaction stayed like this for 2 days and each time I tried to eat anything -even soft foods like yogurt- the roof of my mouth blistered up. My esophagus and epiglottis felt damaged. I ended up not eating much for a couple of days due to the pain and reactions.

About 2 hours after receiving the vaccine, I started to have kinda like tunnel vision, my ears felt cloggd. Tachycardia, palpitations, nausea/vomitting, extreme Fatigue, weakness, headache, dizziness, and loss of memory. I had this type of episode 2-3 times over 5 days, lasting about 20-30 minutes, last one being at work, all of a sudden, same type of episode. Went to ER after Coworkers stated I was " in coherent " or in and out, my BP upon arrival to er was in the 160's/90's. They ran multiple lab tests, CT head, CXR and ECG. By the time I was dicharged my BP was normal I believe it was 116/81. Some side effects like nausea lasted a week, I was given an antinuasea prescription

Within a couple minutes of receiving shot, felt pain at injection site that traveled up arm into neck. Heart rate went up to 122bpm. Left side of face felt puffy and numb. Left side of mouth and tongue were tingling. Reported this to vaccine giver, he had me wait about half an hour before suggesting Benadryl. Half an hour after 25mg Benadryl, symptoms were almost completely resolved. The next day (3/14) I felt tired. The day after (3/15) I felt hot and my skin was flushed. I was not running a fever. I generally felt unwell that day. I felt better by the time I woke up on 3/16. I also had a bad/metallic taste in my mouth through 3/21, which has resolved. My nurse practitioner suggested that I take Benadryl before I receive my second vaccine dose on 4/3/21.

Lip tingling 15 minutes after vaccine administration, which then led to constant full body itching; worse around lymph nodes (axillary, neck, and inguinal). No rash, fever, shortness of breath, swelling of tongue/throat/lips, eye redness, palpitations, fever. Erythematous skin.

Developed lip swelling, mouth numbness/tingling, dizziness, and difficulty breathing within 30 minutes of receiving the vaccine. In light of the lip swelling (angioedema), she was given Benadryl and epipen at the clinic and transferred to ED for further evaluation. She received Solumedrol and Pepcid. Discharged on prednisone Pepcid, and Allegra, after about 2 hours of observation in ED with gradual decrease in swelling of her lips. No shortness of breath at discharge.

3-23-21 4:16PM PT STATES 'EYES FEEL WEIRD, HARD TO REFOCUS QUICKLY AND EARS RINGING'. PT PLACED IN CHAIR. A/O, PINK, W/D, RESP REG WITH EASE. PERLA. NO NEURO DEFICIT. GOOD MOTOR/SENSORY NOTED. COMFORT GIVEN. 4:17PM STATES SHE 'FEELS BETTER NOW'. 4:25PM AMBULATORY TO EXIT - GAIT BRISK AND STEADY. NO DISTRESS NOTED. 3-24-21 9:45AM PT STATES SHE 'FEELS MUCH BETTER'.

Sore arm March 19-20 Fever began March 21 to present, ranging in 99 degree range daily. Lowest 99.2, highest 99.6. Also experiencing chills, lymphnode on left side of neck, little to no appetite, diarrhea, full body aches, dizziness, ringing in ears, knee pain, headache, nausea, sweating, tiredness. I have not been to work this week.

5 days after the shot, severe rash appeared all over upper body. Scalp, face, neck, ears, upper back and upper chest. Also one small patch on lower arm. Ears became swollen. Swelling of lymph node in neck on left side (same side as the shot). Took Benadryl for 4 days but rash and swelling remained unchanged. Went to doctor on 4th day after the rash started (9 days after the shot) and she prescribed Hydroxyzine for rash. Follow-up visit scheduled for 3/31/2021.

Severe Asthma; pain at injection site; Rash at I she tin site the went down left arm, up shoulder and into neck; SOB; weakness; Coughing with taste of blood; running nose; watery eyes; fever; chills; muscle weakness to the point of falling down and dropping item; pain; numbness and tingling throughout body; numbness and tingling throughout body; flank pain; intermittent urinary inconstance; increased urination at night; nightmares; dizziness; blurred/double vision; ringing in ears; irregular body temperature; anxiety; depression; extreme fatigue; visual disturbance; I have been not been to work since second shot; This is a spontaneous report receive from a contactable consumer (Patient herself). A 41-year-old non-pregnant female patient (patient was not pregnant at the time of vaccination) received first dose BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection with false Lot number: EK5730) via intramuscularly on 18Dec2020 at 08:00 am to right arm (at the age of 41-years-old) and second dose with lot number: EK9231 via intramuscularly on 08Jan2021 at 08:00am to left arm both at single dose for COVID-19 immunization. Medical history included Migraines. Concomitant medications were not reported. On 08Jan2021 at 06:00pm, the patient experienced pain at injection site, rash at injection site went down left arm, up shoulder and into neck, SOB, fatigue, weakness, coughing with taste of blood, running nose, watery eyes, fever, chills Day after and progression: muscle weakness to the point of falling down and dropping item, pain, numbness and tingling throughout body, flank pain, intermittent urinary inconstance, increased urination at night, nightmares, dizziness, blurred/double vision, ringing in ears, irregular body temperature, cough tasting blood, anxiety, depression Today: SOB, couch tasting blood, extreme fatigue, visual disturbance, nightmares, anxiety, depression and she said , that she had not been able to work since her second shot. On 13Jan2021 patient underwent lab test included swab test results as negative. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04Mar21 new onset of severe asthma was diagnosed. Outcome of events was not recovered. Information about report seriousness has been requested; Sender's Comments: Considering the known safety profile of the drug and a plausible temporal association between the reported events and the suspect drug BNT162B2, a causal relationship cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

RN notified vaccine administrating RN from facility after pt. c/o itchy lips, weakness and feeling "fait" in post-vaccine waiting room. At 2:05 with pt. experienced difficulty breathing. RN gave epinephrine 0.5ml pt. on R deltoid. Then, 911 was called. Pt. was examined by paramedics refusing to go to ER. RNs encouraged pt. to see PCP. Pt.'s husband was called by pt. for ride home.

Ringing in ears; Urinary incontinence; Urinary frequency; Flank pain; inability to control temperature; Sweating; she was having hot or cold; Wheezing; falling down stairs; Muscle weakness; Blurred vision; Double vision; Inability to work; Rash; Injection site pain; Runny nose; runny eyes; cough with taste of blood; Shortness of breath; Fatigue; Fever; Chills; Dizziness; This is a spontaneous report from a contactable Nurse. A 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EK9231), via an unspecified route of administration in left arm on 08Jan2021 at 08:00 AM (at the age of 41-years-old) at single dose for covid-19 immunisation. The patient received the first dose vaccine BNT162B2 (LOT: EK5730 and EXP: Mar2021) on 18Dec2020. The subject had a history of ongoing Migraine. Relevant concomitant medications were unknown. The patient stated that after her second dose on 08Jan2021, the reaction started at 06:00PM that night. She says she had a rash and injection site pain that went her arm to her shoulder and neck. She says she had a runny nose, runny eyes, cough with taste of blood, shortness of breath, fatigue, fever, chills, and dizziness that night. She says she did not do any treatment that night, she thought the fever would run its course. Caller says that the next day she had severe fatigue, shortness of breath, wheezing, runny nose and eyes, and she also started to fall down stairs and had muscle weakness. She says she had blurred and double vision, and ringing in her ears. She says she progressed from that in a week to having urinary incontinence, intermittent frequency at night, flank pain, and an inability to control her temperature. She says she was having hot or cold sweats and chills which continued quite a while. She also reported that she has gained back muscle control, though she still has days where she is extremely weak, and her dizziness comes and goes. She says that the ear ringing has stayed the same, and her shortness of breath has stayed the same. She says that as of Mar 2nd she has been diagnosed with severe asthma, and she has never had any type of asthma or breathing problems before. The reporter stated that that this was disabling, she hasn't been able to work since 08Jan2021. The reported events were inability to work (impaired work ability) on 08Jan2021, rash on 08Jan2021, injection site pain (vaccination site pain) on 08Jan2021, runny nose (rhinorrhea) on 08Jan2021, runny eyes (eye discharge) on 08Jan2021, cough with taste of blood (haemoptysis) on 08Jan2021, shortness of breath (dyspnea) on 08Jan2021, fatigue on 08Jan2021, pyrexia on 08Jan2021, chills on 08Jan2021, dizziness on 08Jan2021, falling down stairs (fall) on 09Jan2021, muscular weakness on 09Jan2021, vision blurred on 09Jan2021, double vision (diplopia) on 09Jan2021, ringing in ears (tinnitus), urinary incontinence, urinary frequency (pollakiuria), flank pain, inability to control temperature (body temperature abnormal), sweating (hyperhidrosis), wheezing on 09Jan2021 and feeling of body temperature change. Clinical outcome of the event inability to work was not recovered, while clinical outcome of all other events was unknown. Laboratory data included pulmonary function test, result: 40%.; Sender's Comments: Based on the current available information, the event Inability to work is most likely related to an intercurrent or underlying condition which is not related to the suspected drug. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

At approx. 1050 pt reported dry mouth, nausea, and feeling need to puke. Pt given emesis bag. Pt dry heaved and reported not eating breakfast. Pt given water and stated she felt better after drinking water. Pt reported no hx of reaction to prior vaccinations. Pt denied throat irritation, itchiness, and rashes. Vital signs assessed at approx. 1056. BP 110/70 mmHg, PR 75 bpm, spO2 99% RA. Pt advised to wait 30 minutes for further observation. Vitals reassessed at approx. 1115. BP 120/80 mmHg, PR 75 bpm, spO2 99% RA. Pt reported no throat irritation and stated she felt fine. Pt advised to sign up on CDC V-safe. Pt left facility with steady gait and unlabored breathing at approx. 1120.

Started with horrible skull pain behind my left ear(Like a bad headache) . Swollen Lymph Nodes so swollen it caused pressure on my ear and pain in outer ear. My NP could not confirm it was from the vaccine. They put me on an antibiotic and steroids and no relief .. then ear drops... I still cannot hear out of my ear completely and the Lymph nodes in neck, collar bone and armpits are still there and it's been 16 days since I had the shot.... I am refusing the second injection because of this. Nothing on right side of body only on left which is the injection side.

Severe allergic reaction to 1st does of the Pfizer vaccine. After 15 minutes "throat clearing" started and between 25-30 minutes my throat got "thick" and my body began tingling all over. My breathing became labored and difficult, my lips were numb. I was immediately administered an EPI pen, and was transported by ambulance to the ER . I was also treated with albuterol, solumedrol, and benedryl. I remained in the ER for the entire day, and was discharged in the evening. I was prescribed Claritin, and prednisone, and given an epi pen. I followed up with my doctor on the following Monday, still experiencing chest pressure and numbness/tingling in my throat/face. The Claritin was continued, and the prednisone was extended. I followed up with another doctor on Wednesday as symptoms were not resolved. Claritin has been increased and am trying to phase out the prednisone. I continue to suffer from tingling in my lips, and chest pressure. Doctors have no idea how long symptoms would last.

3/26/2021 was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening . During the observation period, she experienced an adverse reaction with the following symptoms: dizziness.. and tingling of the tongue Assessment : Time of assessment 1810. Alert and oriented.and anxious, no visual swelling, rash, or redness. Actions taken: Water offered and accepted, VS taken at 1810- BP- 160/94, P- 86, O2- 100%, recheck @ 1824 - BP- 149/101 Medications administered: No medication administered. Disposition: Reports no further symptoms of adverse reaction after observation for 30 minutes. Discharged home. she was advise to follow up with PCP regarding BP. Immunizations Administered Name Date Dose VIS Date Route Pfizer COVID-19 Vaccine 3/26/2021 5:52 PM 0.3 mL 12/11/2020 Intramuscular Manufacturer: Pfizer, Inc

Pfizer COVID-19 Vaccine EUA 3/23: The patient presents with facial swelling and facial swelling. Patient a 41 y/o female with a history of HTN and anxiety presents to the Emergency Department with facial swelling in her left cheek that began today after she received her first dose of the Pfizer COVID-19 vaccine. She had a panic attack prior to getting vaccinated today. She was also feeling anxious while receiving the vaccine and states that she experienced a tingly sensation on the inside of her cheek as well as having a dry mouth. The patient denies trouble swallowing and eating, sinus pressure, shortness of breath, rashes, and dental issues. She notes that she has gone to the bathroom more frequently today but is not experiencing any diarrhea. Additionally, she has taken hydroxyzine for her symptoms. She is allergic to penicillin.. The onset was abrupt. The course/duration of symptoms is constant. Location: Left cheek. The character of symptoms is swelling. The degree at present is minimal. The exacerbating factor is none. The relieving factor is none. Risk factors consist of none. Prior episodes: none. Therapy today: prescription medications including hydroxizine. Associated symptoms: Dry mouth and tingly sensation on the inside of cheek. Associated injury none. She states she had a panic attack upon sitting down in the chair to receive her COVID shot in her left arm. She had to take her anxiety medication there and then later in the day. She states she felt as if the inside of her cheek was swollen and scratchy this made her very anxious and decided to come in to get checked out. She denies any hives any abdominal pain nausea vomiting shortness of breath chest pain or redness at the injection site. She feels mildly improved from an anxiety standpoint now compared to the onset but still mildly anxious. She has a very normal physical exam no neck tongue or lip swelling there is no redness at the injection site she has no hives abdomen is soft and tender or buccal mucosa is unremarkable ultimately patient reassured discussed it is important she get her 2nd COVID shot. She understands return precautions for signs of allergic reaction. She received no medications.

Woke up the next morning with uncontrollable nausea and vomiting. This lasted for 24 straight until I went to the hospital and received an intermuscular shot and a prescription for nausea medication. Also had sensitivity to light.

Saturday morning- hives on body - got benadryl and 40 mg prednisone Saturday 10 am tongue swelling and hives on tongue - epi pen Sunday morning - more hives- benadryl and extra strength pepsid Hives all over body still (Monday, March 29)

Presented self with "H/A". no blurred vision or difficulty breathing. Stated she had just a "lil blurred vision". Also stated had not eaten since breakfast. Came directly to get vaccine after work. Husband driving car, advised if HA worsens, pull over and dial 911. Stated feel better. she thinks it was just nervousness. Allowed to leave observation area.

Driving home from the vaccine I had double vision and a feeling like I was going up and down in an elevator. The next day I had the sore arm, aches and headache as expected. Sunday, started with carpal tunnel pain that extended from my left shoulder through my fingers as well as some vision issues where my eyes sort of had double vision again but I couldn?t blink it away for a minute. Monday morning I felt my right eye suddenly change vision where the one eye suddenly saw at a 45 degree angle. My husband said my eye looked ok but I could clearly see 2 of him and couldn?t blink it away for a solid minute or so. Today my eyes are blurry and I?m dizzy. I reported this to my doctor yesterday to see if what was happening was vaccine related and she asked me to report it here.

41 yr/o female covid vaccinee this AM First dose of pfizer Medication and food allergy, but no vaccinee Throat tight, hot, scratchy Tingling sensation No swelling sensation No rash, itching No dyspnea, wheezing Got benadryl 50mg IM Mild improvement

The following evening - right at 24 hours after receiving the vaccine, left part of upper lip was numb and swollen. No other unusual events. Patient had been achy from the vaccine earlier in the day, but by that time was feeling ok. Numbness lasted about an hour, swelling lasted about 12 hours. Patient did not feel ill or itchy or anything that would constitute an emergency. Patient does have photo documentation of the swelling.

Warm sensation throughout body within minutes of injection. Approximately 20 minutes after shot noticed a feeling of nasal congestion/sinus blockage. Approximately two and a half hours after shot low grade fever and mild headache. Approximately 3 1/2 hours after shot a short bout of ringing in left ear that lasted approximately 15 minutes. Approximately 67 hours after shot bouts of mild vertigo. Approximately 74 hours after shot bout of severe vertigo lasting approximately 3 hours and subsided to mild vertigo until the following evening. 3/31 sinuses finally cleared.

While walking to the observation area after I got the vaccine, I became lightheaded and short of breath. I needed assistance to a chair. Things began to spin, voices sounded far away, I felt like it was hard to breathe and my throat began to close up. I felt really hot - my clothes were soaked with sweat and my husband (and the paramedics) said I was bright red. I genuinely believed I would pass out. When I sat for a minute with my head back I felt more stable. Then I felt like I had pins and needles all over my body, worst in my feet. The symptoms felt like they came in waves - once I sat down I felt less dizzy, but still struggled with my breathing. When one thing got better, another would intensify. After a couple of minutes my breathing felt much better and I got a metal taste in my mouth and my feet really hurt with pins/needles. The whole thing lasted about 8 minutes, when although I felt tired and my clothes were wet, my body felt safe and almost back to normal. I was surrounded by nurses and paramedics who monitored my vital signs and had medicine nearby, but never administered anything. My body recovered on its own and after 15 minutes I felt great and I gathered my things and drove home. The EMT who said goodbye encouraged me to call my doctor if I felt I was getting worse.

Anaphylactic reaction; Tachycardia/she felt her heart going fast; her throat starting to close/ Sensation of throat closure; Upper airway swelling/Increased use of accessory respiratory muscles; she could not breath/Difficulty breathing (without wheeze or stridor); Respiratory distress; her lips and tongue were big and it was getting worse; her lips and tongue were big and it was getting worse; Hoarse voice; Shock; Decreased level of consciousness; Generalized prickle sensation; Red and itchy eyes; Red and itchy eyes; Abdominal pain; The initial case was missing the following minimum criteria: adverse event (unspecified). Upon receipt of follow-up information on (17Mar2021), this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered on arm right on 25Feb2021 08:15 (Batch/Lot Number: EN6203) as SINGLE DOSE for COVID-19 immunization at the hospital. Medical history included asthma. It was reported that the patient was allergic to NSAID, paracetamol (TYLENOL), pollen, cats and dogs; and insect bite/sting. She also had environmental allergies. It was also reported that her sister had breast cancer. Ongoing concomitant medications included spironolactone (SPIRONOLACTONE), vitamin C, cyanocobalamin (VITAMIN B12), calcium (CALCIUM), magnesium (MAGNESIUM), iron (IRON) and zinc (ZINC) all taken for unknown indications since unknown date. She had no other vaccines received around the time of COVID-19 vaccine vaccination. The patient was not pregnant (including at the time of vaccination). The patient received the first dose of PFIZER-BIONTECH COVID-19 VACCINE on 25Feb2021 at 08:15 AM. Thirty minutes after the vaccination (at 08:45), she had an anaphylactic reaction as she felt her heart going fast and was noted to have tachycardia (as an organ involvement), had sensation of throat closure her throat starting to close. She had upper airway swelling with increased use of accessory respiratory muscles, respiratory distress as she could not breath (without wheeze or stridor). Her lips and tongue were big and it was getting worse. She also had the following organ involvements manifested by hoarse voice, shock, decreased level of consciousness, generalized prickle sensation, red and itchy eyes, and abdominal pain. She was administered with diphenhydramine (BENADRYL) IV. She was taken to ER and was also administered with famotidine 20 mg. The events were considered life threatening. The patient recovered from the events on unknown date in 2021.

Pfizer-BioNTech COVID-19 Vaccine EUA 41-year-old female with history of anaphylaxis to fish and cashews, asthma, aortic stenosis, eosinophilic esophagitis, and chronic idiopathic urticaria presenting to emergency department for chest tightness, dyspnea, nausea, vomiting, and throat discomfort following 1st dose COVID-19 vaccination (Pfizer). Vital signs remained normal and stable during this ED visit. On presentation, patient was in moderate distress. Physical exam was notable for retching and tachypnea upon arrival. Patient's presentation consistent with anaphylaxis likely due to COVID-19 immunization (Pfizer). Epinephrine, famotidine, benadryl, solumedrol, zofran, and fluids administered with complete resolution of symptoms. Patient observed for 4 hours without worsening of symptoms. Patient discharged home.

22 mins post vaccination at 10:50, pt c/o swelling on eyes, face and tongue. On site MD and ALS ambulance reported and assisted patient, BP 124/86, pulse 99, BS 108 and EKG normal; no meds given, transported to the nearest hospital by ambulance due to continued altered mental status possible stroke.

Body aches and ringing in my ears started about 5 hours after the shot. I went to bed at 10pm thinking I was feeling ?fine?. I woke up at 1am, covered in sweat, nauseous and the room was spinning. I stood up because I thought I was going to throw up and lost consciousness. After a few minutes my husband called 911 because I was non responsive and vomiting. I gained consciousness as the paramedics were arriving, but had slurred speech and couldn?t see clearly. As they took me to the hospital I was awake and speaking but extremely weak. They did an ecg. At the hospital they did a blood test and ecg. They gave me an IV of fluids which helped. They had a hard time getting my blood pressure for the first few minutes, trying multiple cuffs. Ultimately, they said the echo looked ok, so they discharged me since I was no longer having an emergency episode and advised that I follow up with my primary and cardiologist

angioedema; Developed lip swelling; difficulty breathing; mouth numbness/tingling; mouth numbness/tingling; dizziness; This is a spontaneous report from a contactable other health care professional. A 41-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 41-years-old, intramuscular, administered in Arm Right on 19Mar2021 (Batch/Lot Number: EP6955) as single dose for covid-19 immunisation. Medical history included asthma. No allergies to medications, food, or other products. The patient's concomitant medications were not reported. the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient developed lip swelling, mouth numbness/tingling, dizziness, and difficulty breathing within 30 minutes of receiving the vaccine. In light of the lip swelling (angioedema), she was given Benadryl and epipen at the vaccine clinic and transferred to ED for further evaluation. She received Solumedrol and Pepcid. Discharged on prednisone, Pepcid, and Allegra, after about 2 hours of observation in ED with swelling decrease and no shortness of breath. The adverse event result in Emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown the patient has been tested for COVID-19. Event outcome of lip swelling (angioedema) was recovering, of shortness of breath was recovered, of the remaining was unknown.; Sender's Comments: Based on temporal association and known safety profile of the product, there is a reasonable possibility that the events are related to BNT162b2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

patient reports throat and tongue itching and tongue swelling and scratchiness of her voice, admitted to EC and given Benadryl, Solumedrol, morphine, and discharged home on same day.

3-4 days after the first vaccine I had itchy neck and slight redness. Also, under the eyes I had small red patches that were mildly itchy. It went away after about a week. 4 days after the 2nd vaccine, in those same spots I experienced swelling, redness, itch. 6 days after the 2nd vaccine shot, my primary physician prescribed 3 doses of prednisone and Benadryl to alleviate the itch. Swelling and redness subsided but very mild itch was till there. On 04.05.21 (18 days after the 2nd shot) my face and neck swell up and are red and itchy. I also feel itchy ob my legs and beck. Benadryl did not help.

I waited the 30 min for high risk and about 5 min after I left my face started burning like I had a bad sunburn, started tingling and felt numb. Took Benadryl before bed. Woke up face slightly swollen and a little tingly. By 8am my tongue started tingling. Took 2 Benadryl and scheduled an apt with my PCP. Apt at 1:30 with PCP. Redness across chest & on & off tingling in face, lips & tongue. Slight swelling noticed by the doctor steroid shot & told to continue Benadryl & add pepcid. Still slight face, lips & tounge tingling & swelling.

Pt felt dizzy, sweating, ears were ringing, spots before her eyes. Gave pt water, had her elevate her legs and recline, started to feel better after about 5 minutes.

during injection she had pain in left side of neck. about 1 hours after, she developed blurry vision in left eye and numbness to left jaw and cheek area. took 50mg benadryl and used ice pack. in the morning she noticed swollen left side of face and continued numbness, tingling, which includes some near her eye. some flushed skin to area. Denies facial paralysis or weakness. Her eye no longer has blurry vision.

I started developing a psoriasis-like rash below my lip and spreading down to my chin. I first saw bumps 2 days after my vaccine on April 1. Thinking it was acne, I began treating it with salicylic acid. That did not help and the rash continue to grow and develop bumps like whiteheads. The spreading and discomfort of the rash prompted me to visit my local urgent care. The doctor was unable to say exactly what caused the rash. Then, I began reading about possible vaccine side effects and I saw a picture of a rash that looks just like the rash below my lip. In this article - the bottom picture looks like the rash I have.

- w/in 15 min nausea and slight vertigo. Soreness in left arm. - w/in 45 min nausea & vertigo went away, soreness travelled into left side of neck/head & jar. Sinus pressure and then difficulty swallowing. - w/1n 60 min itching (no hives) and periodic difficulty swallowing - w/in120 min all symptoms dissipated except for slight soreness in left arm.

Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Tachycardia-Mild

As I was walking out of the vaccine sight on 3/10 after receiving my second COVID vaccine, after my required 15 min wait, I noticed my ears starting to get clogged (similar to being in an an airplane ascending) and they started ringing. I didn't think much of it right at the moment because it was warm and windy thought it might be the storm and pressure change (I've never had an issue with storms/pressure in the past though). The clogged feeling lasted approximately 45-60 minutes and then just stopped. The ringing has been pretty consistent since. It is a lot less noticeable in the day but at night when it's really quiet it's much more noticeable and loud.

Hives worsening over 2 week period causing lip and face swelling. Also had body ache, fever, and headache for 2 days. Prendison prescribed with Benadryl, follow up appointment in 2 days. If symptoms worsen or trouble breathing or swallowing go to emergency room.

Got Pfizer-BioNTech COVID-19 Vaccine EUA about 5:55 pm on Thursday April 8th. Started to feel sorness after 10 minutes at the shot site. 3 hours after got like a whoosh sounds in ears. Sore left arm. Went to bed. Woke up with a headache and feeling drowsy. took acetaminophen at 9am. Headache is gone. Still drowsy. It is 2:15 pm on Friday april 9th. And whoosh sounds in ears came back like 30 minutes ago.

Pfizer-BioNTech COVID-19 Vaccine EUA first dose administered approximately 2:52pm. Reaction started approximately 2:57pm after seated in observation area; sense of feeling "not right" then heart started racing, chest felt tight, vision got strange and I couldn't really move. Once this episode passed I got up and told a volunteer I thought I was having a reaction. Moved to secondary observation area, hooked up to machine that tracked heart rate and blood pressure. Next episode occurred at approximately 3:10pm; heart rate shot up to 160 (unsure of BP), same feelings of immobility accompanied with urge to pee/poop. These episodes continued for 4-5 rounds until approximately 4pm and lasted multiple minutes each time.

Patient came to Vaccine POD to receive first dose of Pfizer vaccine (LOT #ER8731, Expires 07/2021) on 4/10/2021. Patient has a medical history of hypertension and has allergies to ibuprofen and penicillin. Patient received approval from her doctor and specialists to receive Pfizer vaccine. The patient gave verbal consent to receive the Pfizer vaccine and was vaccinated at 1459 by RN. The patient was given an observation time of 30 minutes with RN, who was performing the EMT observer role on site. At 1530, the patient reported experiencing "tingling" in her lips and tongue. Lead RN was called to assist with the patient. The patient presented with redness localized on face. The patient was assisted to anti-gravity chair at 1531. At 1532, the patient's vitals were taken by RN: BP 160/90, HR 83 BPM, RR 21/min. RN administered 50mg/1mL Benadryl IM in the patient's right arm at 1537. The patient denied difficulty breathing. The patient's vitals were reassessed every 5 minutes for 30 minutes. The patient remained A&Ox4 throughout 30 minute observation period. The patient's vitals at 1538 were: BP 200/118, HR 88 BPM, RR 22/min. The patient states she forgot to take her blood pressure medication in the morning. She states her baseline blood pressure is around 160 systolic. At 1543, the patient's vitals were: BP 160/102, HR 90 BPM, RR 22/min. Visibly, the patient was less flushed. Patient was able to look at herself through her cell phone camera and pallor returned to normal limits, per patient. At 1548, the patient's vitals were: BP 155/108, HR 83 BPM, RR 20/min. At 1553, the patient's vitals were: BP 160/102, HR 79 BPM, RR 18/min. The patient states the tingling in her lips and tongue has resolved. The patient sat up with her feet dangling below her, her vitals were as follows: BP 167/110, HR 79 BPM, RR 17/min. The patient reported "feeling better" and requested to drive herself home. RN provided patient with education about side effects of Benadryl, including fatigue. Patient states she is unable to find a ride and must drive herself home. Patient states she is "feeling fine" and lives "3 minutes away". The patient was given education related to when to seek medical care, including shortness of breath, chest tightness, and sensation of throat tightness. The patient demonstrates understanding of teaching and states she will call her doctor if her symptoms worsen. The patient's gait was steady and patient denied any dizziness or lightheadedness. At 1601, the patient requested to drive herself home. She was escorted to her car by RN. Upon departure, patient was ambulatory, A&Ox4, with no reports of trouble breathing, dizziness, or lightheadedness. Patient drove herself home AMA at 1604.

Approx. 36 hours after the first shot, I noticed an intense ringing in my ears that has not gone away. For the first 48 hours I also experienced dizziness, confusion, mood swings, and soreness in my arm. I still have occasional dizziness and mild vertigo.

Pins and needles in mouth and tongue 1 day following vaccine. Continued worsening until going to ER April 10th, pins and needles and burning all over body for a full day period. Continuing to get worse. Have been referred to rheumatologist and neurologist, but no one knows what is going on or how to treat. Only tell me ?I am not the only one?. Feels like arthritis in hands. Pain mostly in mouth, tongue, spine, feet, legs.

I got a little light headed a little while after the shot, but when I woke up the next morning, I was very dizzy and lightheaded with a lot of pressure in the ears. I had no other side effects -- no fever, no nausea, even the arm was barely sore. I am still experiencing all of the same symptoms and at times they can be quite severe. We are thinking that the vaccine caused my vestibular system to flare up and so far it is not turning around.

She states that 1 minutes after receiving the COVID vaccine in her right shoulder, she noticed increased pain, swelling, itching, redness at the site of the injection. She also noticed that her right shoulder became numb and tingly which spread into her upper neck, distal right arm and right lower extremity. She also endorses numbness of the right side of her face and mouth. She denies any muscle fatigue or weakness. She states that after receiving the vaccine she became dizzy and lightheaded upon standing but denies any loss of consciousness.

Following symptoms were experienced about 7 minutes aster receiving the vaccine: Feeling of warmth in abdomen followed by increased heart rate and palpitations. HR 148/min (normal resting heart rate 50-60/min). Blood measure 150/100 (baseline around 115/80). Also feeling of dry mouth. Observation prolonged - BP dropped to 130/90 after about 30 minutes, HR dropped to 80. Episdoes of increased HR kept re-occurring for about 2 hours after the shot. No respitatory distress or cutaneous symptoms. After about 90 minutes after the vaccine, feeling tingling in lips and scratchy throat. Administered Benadryl 25mg per mouth, lip tingling and scratchy throat resolved within 30 minutes thereafter. All of the above symptoms resolved about 4 hours after the vaccine, HR at 60. Following symptoms developed within 12 hours of the vaccine: Chills, fever (100F), myalgia, artralgia, fatigue, nausea. Treated with ibuprofen and acetaminophen, resolved about 48 hours after the vaccine. Note: No known history of Covid.

1. Right side of jaw immediately got very tight and stiff and painful, still has not gone away 5 days later 2. Tip of tongue slowly became weird/numb feeling, has not subsided 5 days later

I began feeling extreme pain, nausea, fatigue and headache within a few hours of the shot. The joint pain and fatigue increased and has persisted as of Monday (day 5 following first dose) becoming extreme at times. I have severe headache on and off. I threw up 2x a day from Thursday-Sunday. My lips began tingling on and off on Wednesday evening April 7 and that has continued ever since. I have also had tingling in my extremities especially my legs and feet, but also my left hand. Fatigue has not improved and as of today, I began to get worse (onset of chills and fever as of 4/12).

Reports to virtual urgent care one day after 1st pfizer covid vaccine with pain in left neck , blurry vision, left facial numbness immediately after. The next day face is still numb/tingling/red. No other symptoms. Advised to follow up with PCP or go to ED if symptoms worsen.

Sore arm near injection site, Achy joints, chills, head feeling hot, intense headache for 5 hours, blocked right ear

Client received first dose of COVID vaccine @ 11:55am, began feeling dizzy @ 12:00pm. Vital signs stable, placed in a zero gravity chair. At 12:04 pm, client complained of tingling in lips, no shortness of breath. Dizziness and tingling lips resolved @ 12:30pm, instructed to follow up with primary care MD. Client walked out of observation area with significant other.

Phantom smell of cigarette smoke, started 2 days after my shot off and on. It keeps increasing in frequency and duration. I?ve had symptoms for 10 days now.

For 6 days after the shot I experienced a metal taste in my mouth and tenderness in left tonsil with a sore throat.

*Lips tingled then went completely numb - started 30 minutes post shot and lasted for about 2 hours *Burning flush feeling - like "niacin flush" - felt over face, neck and upper body starting about 45 minutes post shot and lasting for about an hour *Severe headache / migraine - started slowly about an hour after shot and built up to migraine at 2 hours post shot. Lasted for almost 2 days and then went away to dull headache on 2nd morning after shot. Took Tylenol starting 8 hours post shot and repeated every 6 to 8 hours. *Brain fog / inability to concentrate - started 3 to 4 hours after shot most severe 6 to 10 hours post shot. Slowly came back with 2nd night of sleep. *Dizziness - started 40 minutes post shot while driving home. Most severe about 2 hours post shot then lessening. Lasted a day and a half and then just went away. *Severe Arm pain - pain in injection site arm for so severe that I couldn't move the arm above chest level or touch it against anything for a day and a half. Woke up on 2nd morning after shot and pain is completely gone.

Pfizer-BioNTech COVID-19 Vaccine EUA. Shortly after injection, during the initial 15 minute waiting period until 5 or 6 hours later, there was a weird taste in my mouth and a tightness in the back of my throat, as though the glands were swollen and constricted my throat making it uncomfortable to swallow. There was no pain. Between a rating of 1 to 10, the discomfort level was about 5. I also felt weakness in my whole body and walking felt strange and lasted for the entire day. The injection site has mild soreness even 24 hours later.

Two weeks after getting the second dose of the vaccine, I had two episodes of vertigo. I have no history of vertigo. I also developed bouncy vision where it looks like things are bouncing up and down or moving side to side when I walk or turn my head. It has not resolved. I am scheduled with a neurologist on 5/4/21 to determine if I have any vestibular damage. It is possible this is permanent and at this current time it is very disabling. I am not sure if this is related to the vaccine but I thought it best to report it in case other reports of this come up.

Loss of taste Metallic taste The morning after I received the first dose, I woke up with a strong metallic taste in my mouth. It lasted for a couple of hours. Then it became a total loss of taste (unable to taste any food) that lasted about 8 hours. I also experienced a partial and minor loss of smell, which also resolved in about 8 hours.

Within 2 hours after vaccination, developed pain behind her right ear. Felt as if there was fluid and affected her hearing. She took Tylenol at that time. Around 2 a.m. the following morning (4/15), she rolled over in bed and felt a sharp pain on the left side of her neck. She got up and looked in the mirror and saw that the area was swollen and continued to get larger as the morning went on. She didn't take any medication this a.m. Took her child to school and then came for evaluation.

Dizziness, numbness in face, tongue, and throat feeling tight. 4:00 PM Vital Signs: BP 116/78 HR 40 O2Sat 97% Skin Signs: Diaphoretic, Other - Cool fingers Circulation: Cap Refill <2sec Respiratory: Breath sound clear bilaterally Initial Treatment: Approx 10 min after vaccine, tongue and lips began to feel slightly numb. Briefly a little dizzy, but that soon passed. Taken to triage at 4:05 PM when numbness increased. 4:15 PM Vital Signs: BP 124/76 HR 66 O2Sat 98% Skin Signs: Cool and dry Circulation: Cap refill <2sec Respiratory: Breath sound clear bilaterally 4:30 PM Vital Signs: HR 69 O2Sat 96% Skin Signs: Cool and dry 4:40 PM Vital Signs: BP 130/78 HR 67 O2Sat 99% Notes: Decision made to call husband to transport to hospital. Face and tongue feeling worse. 5:00 PM Vital Signs: BP 132/80 HR 62 O2Sat 99% Sent to ER with husband 5:10 PM 04/14/2021: 11:45 AM: Follow up phone call to patient. Doing very well today. Stated she was observed in ER for 1 hour last night. Symptoms gradually subsided over 4 hours. No treatment needed.

VERTIGO, VISUAL HALLUCINATIONS, RACING THOUGHTS, INSOMNIA, VISUAL DISTURBANCES (FLASHING LIGHTS, BLACK FLOATERS), SHORT TERM MEMORY LOSS, RINGING IN EARS, LONG LASTING BRAIN FOG NO EFFECTIVE TREATMENT AVAILABLE BRAIN FOG STILL CONTINUING- 4 WEEKS AFTER VACCINE FIRST ADMINISTERED

10 minutes after pain in arm was shooting down to hand and to chest, 10 mins later stomach ache, 30 mins after adminstration tongue, face and throat swelled up. Hand of injection arm went purple, cold and numb. Toes went purple and cold. Had to get taken in ambulance to er hospital due to blood pressure and lack of oxygen. When arrived at hospital broken out in hive,blood pressure went up to 175/104 and severe pain in kidneys, stomach, lower abdominal, legs, arms. Day 2 high blood pressure, fever, hives, stomach, kidney and lower abdominal pain. Painful to urinate and poop.

Around 8:00pm I started experience ear fullness and tinnitus (pulsing with my heart beat) in my right ear along with a mild headache on that side. At 11:00pm I woke up with one of the worst migraines of my life and I was shaking uncontrollably. Only a mild temperature of 99.2. I took two Extra strength Tylenol and 30 minutes later the shaking subsided by the temperature did not. The headache persisted until 11:00am on Friday. Migraine symptoms included aching and shooting pains on the right side of my head near my temple, neck pain, light and smell sensitivity. I also smelled things that were not there--like the smell of burnt toast and garlic. I regularly get migraines and have seen a neurologist for these, but do not take prescription medication. I had tinnitus in the same ear about 12 years ago, but have not experienced symptoms since.

Developed arm soreness, headache, and right eye swelling with eczema a few hours after 2nd dose. Had whole body aches and chills throughout the night. Woke up with swollen, red, itchy face. Had fatigue and dizziness throughout next day. Side effect subsided within 24 hours. 6 days post 2nd shot, developed face swelling, redness and itch. Woke up the morning of 7 days post 2nd shot with extremely swollen eyes, cheeks and lips that were red and burned. Went to ER and received 3 IV drugs, including Benadryl, took 3d of oral prednisone and also a topical steroid prescribed by dermatologist. Swelling and redness subsided within 48hrs but flared again 14d post 2nd shot. This flare was mild compared to d7, is limited to mild swelling of lips, redness and itch of lips and eyelids and is being treated with topical steroids.

he evening of 3-4-21 when I got home from work, I ate dinner, then started shivering badly with temp of 100.5. The shivering quickly changed to more of a convulsing and temp got up to 104.7F. When I woke the next morning, temp was back down to 101-102F and most of shakes were subsiding. But I noticed that I had a deep, cutaneous pain reaction from head to toe when I awoke on 3-5-21. I could not brush my hair because my scalp was too tender. I couldn't let anything touch me and put pressure against any part of my body. Then at 3:30 that afternoon, I went to bathroom and had a bowel movement. It was so excruciating that I truly though my colon might have come partially out. I was in too much pain to flush, so I crawled across the house to my bed and laid on my side for an hour, crying. When I was finally able to go back to the bathroom to flush, I was expecting a large BM. It was not. It was about 2" x 1" and soft. There was no blood. It just felt like it tore me up. ****Then at 7:30 PM on 3-5-21 was when things got very serious. I was sitting down watching TV after a light meal. Suddenly, I started noticing discomfort deep in my upper back, between my shoulder blades. Within 5 minutes, it was at its worst....I was have rated it 11/10 pain. The pain was just very deep, behind the spine, about palm sized radius and unrelenting. My first thought was "maybe this is musculoskeletal since I've been in bed a lot because of the pain today." So I looked in my medicine cabinet for what I had and took 5 mg of Oxycodone and 10 mg of Cyclobenzaprine. An hour later, these meds hadn't touched it. I was beginning to really worry about an MI, or aortic dissection or pulmonary embolism (though I had no SOB). Lying flat on my back on a hard surface seemed to provide the only relief (though minimal relief, 9/10 pain). I called another provider who was on call and told her. She said that I could try taking 800 mg of Ibuprofen, but if I wasn't relieved in 1 hour, I needed to call 911 or have someone take me to the ER. I was asleep in an hour. I took it easy the next two days but started feeling back to normal during the days. I continued to sweat throughout the nights and skin pain continued so much that I had to cut some of my hair out. That following Tuesday, the deep upper back pain returned.

Soreness in arm, back pain and fever of 100.4 as of 5:25 pm in 4-17/21. Extreme fatigue, body aches and my eyes are feeling dry as well.

Migraines resistant to OTC NSAIDs. I woke up with the migraine on 23 March. Pain phases lasted multiple days, with multiple nausea, visual disturbance, aphasia, and facial neuropathy phases. These have been common for me in the past, but have only rarely occurred the last few years. Migraines would fade after 3-4 days, then come back 1-2 days later for the 3 weeks following the injection.

Rash developed on Monday after Friday shot. Bad reaction on the top of my right hand, as well as a sight rash on my left wrist, top of left hand, bottom lip. By Tuesday right hand was blistered and extremely painful, with blisters. By this morning, skin was peeling and revealing very pink new skin. Painful burning sensation throughout.

Mouth & throat felt numb & tingly; Mouth & throat felt numb & tingly; Mouth & throat felt numb & tingly; Mouth & throat felt numb & tingly; She felt panicky, because it felt like her throat was "closing"; very odd, uncomfortable feeling; This is a spontaneous report from a non-contactable consumer reported for herself. This 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 31Mar2021 in left arm at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 31Mar2021, the patient experienced mouth & throat felt numb & tingly. She felt panicky, because it felt like her throat was "closing". It was a very odd, uncomfortable feeling that lasted roughly 1.5-2 hours. It scared her. No treatment received for events. Patient did not have COVID prior vaccination, and did not test COVID post vaccination. The outcome of events was recovered on unspecified date. No follow-up attempts are needed. No further information is expected.

4/18/21: Awakened with a loud, sharp ringing in my right ear. The ringing is consistent and bothersome and causes a feeling of being "off". 4/17/21: Nausea, headache, and mild fever

face hurts; Tooth hurts; This is a spontaneous report from a contactable consumer (patient). A 41-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 01Apr2021 (Lot Number: ER8737; Expiration Date: 31Jul2021) at SINGLE DOSE in Left shoulder for covid-19 immunisation. The patient medical history was not reported. No Prior Vaccinations (within 4 weeks). The patient's concomitant medications were not reported. The only medication she takes is cholesterol pills. She received her first dose of the Pfizer Covid 19 Vaccine this morning and ever since she came home, her tooth hurts and her face hurts on 1Apr2021. She would like to know if teeth and face hurting are side effects from the vaccine. She reported her teeth at the top are hurting, teeth on the bottom are okay. Said its the both sides of mouth on the top that are hurting. The patient reported this is happening off and on. The outcome of Tooth hurts was unknown, of face hurts was recovering. No follow-up attempts possible. No further information expected.

Pt c/o tickle in throat which began a few minutes after vaccine administration. Tickle/ dry sensation in throat alleviated with water. Throat itchiness better, discharged home. ED precautions given.

A day after receiving my first vaccine, the onset of ringing in my ears began and my ear felt full and I had dizziness. I went to my primary Doctor and she ruled out ear infection and referred me to an ENT doctor and an audiologist. They gave me an audiogram and then the ENT doctor could not give a definite diagnosis except that I now have hearing loss in both my ears and tinnitus could be a chronic issue. I continue to suffer hearing loss and tinnitus in my ears since I received my vaccine and it continues to this day.

Patient reported at 1213 tingling/numbness in her lips, right side of face and throat with redness and mild facial swelling of the right cheek. Pt. stated feeling "a sense of doom." She felt warm to the touch. Denied chest pain or dyspnea. 911 called at 1213. FD station is steps away from our site, so we rang their doorbell and they responded and were on site at 1216 with their 3 BLS supporting the 3 RN's on site mananging the event. Vitals #1: @1214 BP 180/100, P 100, RR 24, O2sat 98%. Vitals #2: @1219 BP 180/120, P 85, RR 22, O2sat 98%. ambulance arrived at 1220. Pt. remains with same and not worsening symptoms. Vitals #3: @1225 BP 150/120, P 98, RR 22, temp 100.1F. Pt. left in ambulance at 1230.

Weakness of Right Eye; Numbness in right eye; Feels tugging in the back of her head and symptoms around right eye; Weakness in arms and legs; Feels tugging in the back of her head and symptoms around right eye; Neuropathic Symptoms on Right Side of Face; Numbness on Right Side of Mouth; she started experiencing weakness in the right eye and on the right side of the face, which is the same side as her Bell's Palsy, and the corner of mouth started to have numbness; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE,Batch/Lot number was not reported) via an unspecified route of administration on 29Mar2021 (at the age of 41-year-old) as single dose for covid-19 immunization. Medical history included facial paralysis from 1998 to an unknown date, Bells palsy at age 18 , ongoing temporomandibular joint syndrome , asthma exercise, depression, pain, hypoaesthesia, Numbness in face in the past (June 2020 tele-visit with neurologist), fatigue, headache, anxiety. Concomitant medications included gabapentin (GABAPENTIN) taken for neurological symptom, hydroxyzine (HYDROXYZINE) taken for anxiety. The patient experienced she started experiencing weakness in the right eye and on the right side of the face, which is the same side as her bell's palsy, and the corner of mouth started to have numbness on 01Mar2021 with, neuropathic symptoms on right side of face on 01Apr2021 with, numbness on right side of mouth on 01Apr2021, weakness of right eye numbness in right eye, feels tugging in the back of her head and symptoms around right eye, weakness in arms and legs, feels tugging in the back of her head and symptoms around right eye. Caller states basically she had Bell's Palsy years ago and was left with cranial nerve damage. She stated she noticed after the first Pfizer vaccine, that in that area of the face that she had Bell's Palsy, she started having neuropathic symptoms. and stated that it started thursday. States it has been there for a couple of days and she still has a little bit of neuropathic symptoms but not as great as when the onset began. The outcome of the events was recovering. Information about batch/lot number has been requested.

Pfizer-BioNTech COVID-19 Vaccine EUA: patient experienced worsening left-sided facial droop, dizziness, tongue heaviness, and weakness within minutes after reciving vaccine. Vital signs within normal ranges except for blood pressure 141/06. Patient observed and monitored, diagnosed by neurology with myasthenia flare, and discharged to home ambulating independently and stable.

I felt fine until I got up in the middle of the night to use the restroom. It was when I tried to get up from the toilet that I lost consciousness and fell forward. My husband discovered me laying there some time later. Before passing out I felt hot, and my ears were ringing.

1400 - Patient complaint of "feeling funny" and "my tongue feels weird." Patient taken to treatment area to be assessed. She then stated that it "was hard to swallow." BP = 158/94, HR = 109, O2 Sat = 99% 1402 - Nurse assessed patient and implemented COVID vaccine reaction order set - patient given Benadryl 50mg PO. 1409 - Patient given Pepcid 20mg PO and monitored for 30 minutes after medication given. BP = 146/97, HR = 92, O2 Sat = 100% 1435 - Patient stated she feels fine and would like to leave. Recommended she follow-up with PCP to see if they recommend for her to receive 2nd dose when scheduled, and to inform staff if getting 2nd dose of previous reaction. BP = 152/93, HR = 95, O2 Sat = 100%

Patient complained of itchy and dry throat. Denies swelling, difficulty breathing, and itching. The doctor on site evaluated her. Vital signs stable. Felt better after drinking water. No problem swallowing. Symptoms resolved completely and she was discharged from the vaccine clinic.

Patient had itchy, dry throat. BP 143/98 -- > 144/98 -- > 118/78 (11:09AM), HR 86 -- > 77 -- > 63, RR 16, O2 100% -- > 99%, Temp 99F -- > 98.8F. Given Benadryl 50 mg IM at 10:50AM. Patient stable and released from vaccination site at 11:21AM.

Major symptoms are plugged/whooshing/ringing/popping ears. Pressure in my head. Dizziness, especially when I look up after looking down at my phone. My hands and feet get so cold they hurt. I can put my frozen feet by my space heater and they don?t warm up, they just hurt more. Inability to concentrate and foggy brain. During meetings I find myself starting sentences but I can?t finish them, it?s like I stop and wait for my friends/family/coworkers to finish my thoughts. Other symptoms that don?t bother me as much. Constant sinus drainage and occasional sneezing. Dehydration. Insomnia and vivid dreams.

blood vessels in her left eye popped and eye looks bloody; Caller adds that it is gross; Caller adds that it looks like it is getting red, more red, it does not look like it is spreading but it is getting darker; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in arm left on 05Apr2021 10:15 (Lot Number: ER8732) at age of 41 years old as single dose for covid-19 immunisation, alpha-1 antitrypsin deficiency, liver disorder, lung disorder. Medical history included ongoing alpha-1 antitrypsin deficiency, ongoing factor v leiden carrier, ongoing bipolar disorder, diabetes mellitus (she did not know if it meant anything but it turned out they were both very very diabetic. She adds this scares her, she does not want a needle), iron deficiency, vitamin d deficiency, lung disorder, emphysema, chronic obstructive pulmonary disease, hypertension, insomnia, depression, dumping syndrome and acid reflux. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. There was no vaccines administered on same date with the Pfizer vaccine considered as suspect. There was no any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. AEs following prior vaccinations was none. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR) taken for alpha-1 antitrypsin deficiency, emphysema, chronic obstructive pulmonary disease from an unspecified start date and ongoing; colestipol taken for dumping syndrome from an unspecified start date and ongoing; dexlansoprazole (DEXILANT) taken for gastrooesophageal reflux disease from an unspecified start date and ongoing; iron taken for iron deficiency; lamotrigine (LAMICTAL) taken for bipolar disorder from an unspecified start date and ongoing; levomefolic acid (L-METHYLFOLATE) taken for depression from an unspecified start date and ongoing; lisinopril taken for hypertension; amlodipine besilate (NORVASC) taken for hypertension from an unspecified start date and ongoing; alpha-1-antitrypsin (PROLASTIN-C) taken for alpha-1 antitrypsin deficiency from an unspecified start date and ongoing (did not have dosage, she got an infusion into a port once a week. She got five bottles. She was on this for alpha-1, maybe 10 years); tiotropium bromide (SPIRIVA) taken for lung disorder, alpha-1 antitrypsin deficiency, chronic obstructive pulmonary disease, emphysema from an unspecified start date and ongoing (Caller thinks it is a standard, it is once a day. She has been on for 10 years. It does not say anything else, it just says Spiriva handihaler); temazepam taken for insomnia; vilazodone hydrochloride (VIIBRYD) taken for bipolar disorder; colecalciferol (VITAMIN D3) taken for vitamin d deficiency; olanzapine (ZYPREXA) taken for bipolar disorder from an unspecified start date and ongoing; multivitamin (Dosage text: Caller takes one a day, it does not really have a dose, she does not see a dose thing on it. has been taking for about 20 years, Caller states she eats like crap). The patient got her first shot yesterday (05Apr2021), and then woke up with the blood vessels in her left eye were popped, and her whole eye looked bloody. She added this was kind of tripping. She wanted to know if this had anything to do with the shot (Pfizer Covid19 vaccine) or anything else. It was gross, and she did not like looking at it. It looked like there was blood around her eye, and it started when she woke up this morning it was like that. It looked like it was getting red, more red, it did not look like it was spreading but it was getting darker. She clarified and stated that it was a lot of pets. She did start an allergy drop a week and a half ago, Pataday (lot number 102C5, expiration date Dec20211, over the counter) eye drop; it was a 0.2 % antihistamine. Treatment reported as: just the Pataday eye drops, which were for allergies. She did not know what was up with the pollen this year but it was trying to kill her. She started these a week and a half ago. The events did not require a visit to Physician office or Emergency Room. The outcome of events was not recovered. Follow-up attempts are completed. No further information is expected.

My mouth and tongue became itchy about two minutes after the injection. My throat felt strange. My arms were itchy as well. The pharmacist gave me two children's chewable Benadryl. My symptoms remained, so the pharmacist injected me with an EpiPen and called an ambulance. I was taken to the ER at the hospital. By 5:00 pm, the ER staff gave me IV fluids, Benadryl, and steroids. I was experiencing nausea, and so Pepcid was also given via IV. I also had a rash on my arms and legs.

PT COMPLAINED OF ITCHING IN MOUTH AND THROAT . WE GAVE HER Benadryl with no relief than administered an epi pen. we called 911 and pt went to the ER

Pt. had rash on left side of neck to mid-clavicular line and slight ticking in her throat. Pt. denies difficulty swallowing. SOB, other complaints. Pt. was give 50 mg PO diphenhydramine w/ relief from S/S

Tinnitus. I historically have had minor tinnitus, that happens infrequently and sporadically. I had my first vaccination on Sunday and I really noticed this began yesterday on Tuesday, it has worsened and is more frequent than usual. I decided to Google this symptom in regards to the covid vaccine and found this to be an adverse effect I should maybe report. I'm able to work and live normally, it's not that much of a bother at this time. I have not notified my pcp of this, and don't feel I need to be seen by them.

Tested positive for COVID on 4/21.....well after the full vaccination series was completed on 1/7/21. Mild symptoms including loss of taste and small dry cough

I noticed a metallic taste in my mouth around April 12 and I still have it. It seems to have improved but I?m nervous now that it has lasted so long and I?m due for my second vaccine on April 27.

20 minutes after my second shot, I developed wheezing at the base of my throat. It did not escalate to full anaphylaxis but remained a steady wheezing feeling for a number of hours after. It dissipated be evening but returned 4 days later along with tingling in my lips that comes and goes. It continues on and off 2 weeks post vaccine. I do not have any other illnesses or reasons to think this other than a side effect from the vaccine. I do not have a history of asthma either.

Day of vaccine, approximately 2 hours later, the left-side of my face went numb for approximately 8 hours. 6 days later, I experienced chills followed by hot flashes, nausea, dizziness, weakness (needed support to walk), headache and ringing in my ears. The chills, nausea, weakness, etc. came in waves for the next 6 days. The tinnitus and dizziness has stayed.

Severe tinnitus. Both ears have been ringing loudly, constantly for weeks following the vaccine. It has now been at least 2 weeks. Primary physician has referred me to ENT.

41 y/o F w/ PMHx panic d/o presenting with difficulty talking, reporting ?feeling a lump in my throat,? chest tightness/shortness of breath, hazy vision, and tingling in bilateral arms/hands 10 minutes after her first dose of Pfizer (given at 12:03 PM - symptom onset at 12:13 PM). Reports symptoms started suddenly with chest tightness and hazy vision which then resolved after approximately one minute. Reports symptoms then localized to her throat and she felt like she had to gag. After 2-3 minutes of having difficulty talking, she reports she feels like she can fully talk again. Reports her throat swelling sensation has resolved and only residual symptoms are a ?caffeine rush feeling? and tingling in her hands. She did not have water or breakfast today and endorsed feeling nervous prior to her vaccine today. Only medical hx includes panic d/o (occasional - last panic attack 1.5 yrs ago). Not on daily or prn medications and never has been; no h/o seeing psychiatry or therapy. Reports her current symptoms feel different than other panic attacks. No other chronic conditions or daily meds. Denies h/o serious allergic reaction to any medications (oral, intravenous, injections). Reports feeling dizzy with Excedrin PO 10 yrs ago. Never been given Epinephrine. H/o hay fever with weather changes - does not take medications. Pt denies swelling of the face, itching of the skin, rash, CP, dizziness, extremity weakness, HA, n/v, or abdominal pain.

Dizziness/light headedness, fatigue, chills, runny nose, dry mouth Rest, vitamin C, in bed with lots of blankets Outcome unknown

The patient left the vaccine clinic after the 15 minute observation period. While driving home, about 25 minutes post vaccination, the patient developed what she described as "tongue and throat felt funny and stuffy.' She drove to her PCP clinic and was evaluated by a physician. Vitals were normal/baseline (BP=96/68, HR=79, SpO2=100%, RR=14). She was treated with diphenhydramine 25mg by mouth, and Solu-Medrol 40mg intramuscular. Symptoms resolved following treatment and observation. The provider recommended that patient could proceed with 2nd dose.

Tongue felt like it was swelling; Itching; Tickle in her throat; This is a spontaneous report from a contactable pharmacist. A 41-year-old not pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN3518), via intramuscular route of administration in left arm on 02Feb2021 at 11:45 AM at single dose for COVID-19 immunization. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: El1283), via intramuscular route of administration in left arm on 01Jan2021 at single dose for COVID-19 immunization and had no problem post 1st dose. Medical history and concomitant medications were not reported. The patient was allergic to shellfish anaphylaxis. On 02Feb2021 at 12:15 PM, the patient experienced tongue felt like it was swelling, tickle in her throat and itching. During observation period post second dose patient began itching and felt like she had a tickle in her throat. Patient began clearing her throat and asked for some water. RN noted she was rubbing throat and gave her water and benadryl 25 mg PO for itching. Patient noted that her throat was starting to feel funny like it might be closing up and her tongue felt like it was swelling. Epinephrine 0.3mg IM administered immediately after identifying these symptoms and patient wheeled down to ER for evaluation. Patient received IV benadryl in ER and famotidine. Observed for a couple of hours and then released. The outcome of the events was unknown.; Sender's Comments: A causal relationship between BNT162B2 and the reported events swollen tongue, pruritus and throat irritation cannot be excluded based on temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate .

Since receiving my first Pfizer Covid vaccine on March 18th, 2021, I have experienced nearly non-stop tinnitus in both ears. I still went and received my second dose on April 9th, 2021. I am still experiencing the tinnitus and have an appointment with an ENT today, April 23rd.

9 days after the vaccine I experienced sudden hearing loss in my right ear. There is a marked difference between the left and right ear, and I am relying on my left ear to hear and function. I am reporting this 48 hours after the onset of the hearing loss. Treatment - prednisone, zyrtec, flonase. Outcome - treatment only began 24 hours ago, so it's too soon to tell.

Ninety minutes after injection, face and lips tingled and went a little numb, lost some feeling. Throat went tight and tongue tingled and lost some taste. Throughout the three weeks since it started it comes and goes in severity but has not stopped. One dose of Benadryl was taken and the symptoms did not go away.

For both of my vaccines, I had a noticeable dulling of my senses of taste/smell on the 3rd day following vaccination. Symptoms did not last longer than 12-24 hours

Started 10 minute after the shot I was nauseous with a headache watery eyes , nose I had an asthma attack, the nurse I seen took me to a curtain room and gave me 6 pumps of albuterol my bp was dropping at first and I was extremely weak and I took 2 more puffs and my BP went up now and the nurse wanted me to go to the ER and I got up and almost fell I was so dizzy I was given Benadryl at the hospital and received chest X-rays and was watched over and I was continuing to take Benadryl and albuterol around the clock, I was itchy all over and I?ve had to take my albuterol more often then usual now even though feeling better my heat rate is all over the place and and my period is extremely off as well clotting, tissue passing as the vaccine is now itchy again and swollen and hurting after 2 days as of your symptoms were gone

24 hours after shot had hallucinations, then 3 days later started having sore throat, lost voice, and scratchy chest feeling. no fever, no cough, no sob.

Patient woke up with jaw pain and left arm pain. When this didn't subside, she went to the ER and was found to have an NSTEMI. cath showed no abnomalitys echo showed inferior/infeobasal hypkinesis differential: takotsubo cariomyopathy, viral myocarditis, vaccine reaction Patient wore a heart monitor for a week which showed no abnormalities. Since this time, she has had occasional chest pains, squeezing sensations and pressure. A return visit to the ER because of continued chest pains showed a normal EKG and negative troponin. She is scheduled for a cardiac MRI tomorrow on 4/27/21. She is currently taking 10mg Amlodipine, 25mg metoprolol, a statin and a baby aspirin. The amlodipine seems to have done the most with respect to helping with her symptoms. She does not smoke. 1 glass of wine per week. She is not overweight. She has low cholesterol and low BP prior to this. Only other medical condition prior to this was occasional migraines (2 per year).

At 7:10 am on 4/14/21, I first started shaking uncontrollable because I was so cold w/ chills. Then about 7:30 am I started breathing hard. My eye sight went black for a few minutes, I almost passed out. Both hands went numb for a few minutes. Then I got a fever, highest was 102.7. Had fever off and on all day and body aches then by 2 pm the fever was better. Then at 7:30 pm, I started shaking again and my fever spiked to 104.5. I got it down to 103 and it was like for about 3 hours then it broke. Then for about a week, I was very exhausted and had no energy and couldn't like normal, no appetite. It took me a week to get to feeling better.

Within 10 minutes of receiving her vaccine she developed dry mouth, nausea, lightheadedness, shakiness, and then a tightness in her throat associated with "gagging."

A couple of hours later I had fatigue, cough, joint pain, muscle pain, change of appetited, brain fog & lost of voice. I have not fully recovered from this symptoms. I seen several doctors. On 01/19/2021 I seen my doctor they tested me for covid & told me to rest & go back to work when I felt better. On 02/08/2021 got tested for covid again. On 02/26/2021 I was tested again for covid due to my cough and dry throat. On 03/02/2021, 03/9/2021, 03/15/2021 I was seen by raspatory doctor due to the symptoms that I was having. On 03/25/2021 continued cough anxiety and depression fatigue and pain. On 04/02/2021 I followed up with my pcp for my ongoing issues and she refer me with an ENT. On 04/26/2021 I was seen by ER because of migraines and I don't have a history for migraines. Today on 4/28/2021 I am seeing the ENT for the voice lost.

it started about the 10 minutes after the shot.my lips started swelling up and my tongue started getting tingly on the tip. my arm got swollen and was noticeable by the wrist area on the arm the shot was given on. my neck started to swell up on that side. then my cheak started getting numb like tingly feeling. it started coming up towards my face the numbness . they just gave shot of Benadryl. never had a reaction to a vaccine

She received the vaccine via drive through at the local fairgrounds. Notes she developed swelling around her eyes within an hour. After 24 hours, she turned red, developed swelling on her entire body, and itchiness on her entire body. Notes her joints were painful; unable to make a fist with her hands. Also had a fever. No asthma symptoms. She called Urgent Care for advice, was recommended to take cetirizine or other antihistamines and pain medications. Patient took cetirizine and ibuprofen, symptoms resolved within a few hours. Still has some residual swelling around her eyes but notes it isn't itchy.

Within 10 min left ear was warm and itchy, slowly progressed to left sides of neck and face. Waited full 30 min with no change. EMT advised me to take Benadryl at home after checking for rash. No trouble breathing. On the drive home, my left tongue and mouth went numb and left tonsil swelled slightly. I took 2 benadryl at home and felt better a few hours later. No recurrence as of today. With my first dose of the vaccine, I only noticed immediate nasal drainage.

Feeling of blacking out; Nauseous/nausea; Light headed; Vision clouded over; Ears started ringing loudly; Pale; Vasovagal response; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported), on the left arm on 14Apr2021 (15:15) as a single dose, with route of administration unspecified, for COVID-19 immunization. Medical history included hypothyroidism, allergies and sulfa allergies. The patient was not pregnant at the time of vaccination. Concomitant medication included thyroid (ARMOUR THYROID). On 13Apr2021 (15:15), the patient had a feeling of blacking out; nauseous/nausea; light headed; vision was clouded over; ears had started ringing loudly; was pale; and had vasovagal response. The events had resulted in doctor or other healthcare professional office/clinical visit and emergency room/department or urgent care. The patient had received an anti-nausea medication, fluids and antacids as treatment for the reported events. The patient's bloodwork was fine and vitals were good, both on 13Apr2021. The outcome of the events was unknown. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested post-vaccination. Information on the lot/batch number has been requested.

My eyelids and the area right below my eyes starting swelling and peeling about 48 hours after my first vaccine. After about 10 days, I went to my doctor just to make sure I shouldn?t be worried about a worse after the second dose, but he didn?t think there was much we could do except wait it out (symptoms are annoying but not debilitating). We agreed that I should get the second vaccine. I am still experiencing swelling, itching, and irritation of the area surrounding my eyes (not the eyes themselves) 16 days after my first shot. It is worst in the morning. I have had slight improvement since initial onset, but I am definitely still experiencing symptoms.

didn't feel good; sick; blood pressure went high; smells smoke; pulse change; migraine; This is a spontaneous report from a contactable consumer (patient) via the medical information team. A 41-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of bnt162b2 on an unspecified date, and 5 minutes after she "didn't feel good". The patient was sick, blood pressure went high, smells smoke, pulse change and migraine up until 36 days later. She was on migraine medicine, and that she lost her job because of this. The patient already went to the hospital four times, and her doctor five times. The patient sought guidance on how to remove the vaccine from her system. The patient considered the events as non-serious. The outcome of the events was unknown. Information on the lot/batch number has been requested.

arm numbness and tingling; arm numbness and tingling; feel burning in face; face began to tense up; This moved to swelling of the tongue; difficulty swallowing; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP7533 and expiration date not provided), via an unspecified route of administration, in right arm, on 15Apr2021 16:15 (at the age of 41-year-old, not pregnant), at single dose, for COVID-19 immunization. Medical history included PCOS (polycystic ovarian syndrome), allergies to sulfamethoxazole;trimethoprim (BACTRIM), metoclopramide (REGLAN) and amino acid base in iron infusion. No other vaccine in four weeks, no COVID prior vaccination. Concomitant medication included fexofenadine hydrochloride (ALLEGRA, nasal spray). The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP6955 and expiration date not provided), via an unspecified route of administration, in left arm, on 26Mar2021 16:00 (at the age of 41-year-old), at single dose, for COVID-19 immunization. On 16Apr2021 16:30 (reported as "initially within 5 minutes"), patient developed arm numbness and tingling. Physician prescribed diphenhydramine hydrochloride (BENADRYL) and prednisone. Within 30 minutes, began to feel burning in face and face began to tense up. This moved to swelling of the tongue and difficulty swalliwing. Events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). Patient was hospitalized for 2 days. The patient underwent lab tests and procedures, which included COVID test (Nasal Swab) was negative on 17Apr2021. Therapeutic measures were taken as a result of events and included treatment with epinephrine, methylprednisolone sodium succinate (SOLU-MEDROL), famotidine (PEPCID) and diphenhydramine hydrochloride (BENADRYL). The outcome of the events was not recovered.

On April 4 (throughout the day) -- began to show symptoms of feeling abnormal / off-center (beginning around 10am). by 5pm -- became uncoordinated / unbalanced (couldn't access phone, put on clothes, etc.). Advised by Neurologist to seek ER treatment and directed to local hospital. Initially, diagnosed as showing symptoms of a Stroke. Upon further analysis, hospital determined it was a MS Flare Up. Since April 4 -- patient lost use of left side (hands, legs). Right Side brain also affected. Currently in acute rehab (Since April 17) to regain functionality. As of May 3 -- still unable to walk on her own or use left hand. Still experiencing visual issues. Acute Rehab facility believes recovery may take up to a year. Patient's normal Neurologist was puzzled by diagnosis because the symptoms as well as the duration and acuteness of the episode is inconsistent with her MS condition. Patient was originally diagnosed with MS in 2009 and there have no MS flare-ups since the initial diagnosis. The normal Neurologist noted that the symptoms are inconsistent with her history. Believe it was proper to notify, given the recent vaccination. Can provide full medical records, if helpful

Increased intracranial pressure with vision loss requiring VP shunt placement; Increased intracranial pressure with vision loss requiring VP shunt placement; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in arm right on 23Jan2021 at 12:00 (Lot Number: EK9231)(at the age of 41-year-old) as single dose for COVID-19 immunisation. The patient was not pregnant. Medical history included hypertension (HTN), obstructive sleep apnea syndrome (OSA) and hypothyroidism, all from an unknown date and unknown if ongoing. Known allergies: KEFLEX, LEVAQUIN, Penicillin. Concomitant medication included levothyroxine; lisinopril; trazodone and HCTZ, all concomitants were taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 04Jan2021 at 15:00 (Lot Number: EL0140) (at the age of 40-year-old) as single dose for COVID-19 immunisation. On 26Jan2021 at 14:00, the patient experienced increased intracranial pressure with vision loss requiring VP shunt placement. The events required emergency room visit and physician office visit. The patient was hospitalized due to the events for 2 days. The patient underwent lab tests and procedures which included intracranial pressure (CSF pressure): increased on 26Jan2021, SARS-COV-2 test (Nasal Swab): negative on an unspecified date. Therapeutic measures were taken as a result of the events and included 3 lumbar punctures and surgery for VP shunt. The patient outcome of the events was recovering.; Sender's Comments: The 41-year-old patient had medical history included hypertension (HTN), obstructive sleep apnea syndrome (OSA) and hypothyroidism, and was on multiple concomitant medications. Intracranial pressure increased and blindness were most likely due to concurrent disease, and unlikely related to the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.

This is a spontaneous report from a contactable consumer reporting for the daughter. A 41-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 10Apr2021 (Batch/Lot number was not reported) as single dose maybe the right arm (reporter was unsure) at the age of 41-year-old for COVID-19 immunisation, administered through hospital. Medical history was none. There were no concomitant medications. In Apr2201 the patient experienced she can't hear right now and it won't go away, ringing in ears, she is extremely stressed out and this is affecting her life, she was so upset. The course of events was as follows: She has had ringing in her ears from this, started some time after the shot. She was extremely stressed out and this was affecting her life. She can't live like this. She recently divorced with 2 kids and trying to work. Went to the doctor twice and they sent her to ENT department. This is destroying her life. It was very stressful. Patient was having a severe problem. She had been to the doctor twice, including this week in Apr2021 and once the end of last week in Apr2021. They looked at her medications and sent her to counseling, to therapy. She had definitely not gotten better, has been persistent. She did not know on like a graph scale where it was. She received no treatment for ringing in ears. She was trying to take something for stress because this was horrible. She cannot hear right now and it won't go away. This is a serious problem. Reporter did not want her daughter to go deaf. She received a message from hospital, regarding her being scheduled for the second vaccine on Saturday and she said she was not going for that she wished she had not gotten the first one. Reporter stated she has a good friend who's daughter was a PA whom she has been corresponding to about this and she sent them links of how the Covid vaccine is linked to tinnitus. She has never had anyone report this. She sent it to her daughter and her daughter said can't read this, there is blogs with responses and she just said she can't read this, she was so upset that she can't hear right because of this with this ringing that won't go away. She had gotten a call from the Hospital Department stating that she was ready for the second shot. She was not getting the second shot and was sorry that she got the first one. The outcome of events was not recovered. Information on the lot/batch number has been requested.

Tinnitus in ears, starting loudly in the right ear at 16hrs after vaccination and softer in the left ears. Left ear became louder over the next week. Called primary care doctor twice over the next couple days and saw ENT on 4/28/21 after vaccination. No hearing loss detected and no cure available for tinnitus. ENT was unable to say if tinnitus will resolve over the next few weeks/months. Considering it has been nearly 4 weeks, I consider this to be permanent damage.

The evening of the vaccine I noticed pulsatile tinnitus, which began as a low thudding sound in my head (with pulse). The next day the tone had changed to the high pitch, constant ringing of tinnitus. I also experienced persistent daily headaches for 8 days, which has resolved. The tinnitus has not resolved and ranges in intensity from so loud I cannot listen it focus to background noise.

Bell'sPalsy, left sided facial droop, inability to move the left forehead, left facial numbness, inability to close the left eye

5/12, 5/13 and 5/14 - Arm Pain, specially when trying to lift anything. 5/15, 5/16, 5/17 - noticed shortness of breath, very sleepy, throat clearing, heavy post nasal drip. Weird taste in mouth. 5/18 - Neck Pain 5/19 - Felt a small moving ball on top of the left side of my collarbone, closer to my throat, it is painful and tender to the touch. My neck feels in pain, actually more like a burning sensation

headache with visual sensitivity, headache, hard to hear for a second, speech was impaired for a second, difficult to find words for a second, felts as if she had a fever and kept coming in flashes, pain went down leg, but then quickly went away, index knuckle on left hand felt burning, but went away,2nd day- tiredness, hot flashes, thirsty, 3rd day sleep disturbances, night sweats on each day since vaccine, throat dry on second day, 3rd day throaty dry, lymph nodes swelling, tired, this morning pain in right axillary area, neck still sore, dizziness this afternoon, abdominal upset this morning, hot flashes today

Approximately 3 hours after vaccine, I began to have tingling on my upper lip (area where I typically get a cold sore). Tingling continued to spread to the left side of my face, including my eyebrow, eye and temple area of my head. Tingling has persisted to both of my arms, hands, legs and feet. It comes and goes, and has continued through-out the day. Itching has now developed on my arms, right breast (nipple area) and feet. I have a general "internal" itch that I can't seem to scratch on my arms, legs and feet. On Saturday 5/22, Sunday 5/23 and Monday 5/24 I have also experienced strong nerve pain in my left eye and the lower right side of my head. The pain is sudden, strong but goes away fairly quickly. My left large tie also has developed a numbness, started off with a lot of tingling in that toe. My head generally has a fullness feeling, specifically my ears have a throbbing sensation that I also equate to a similar feeling when my cold sores are active. There is a dull ache behind my ears and the lower back of my head. I developed a headache starting on 5/20 (over the counter meds helped with that) Pain at injection site lasted for 3 days, but was manageable and did not interfere with daily activities. I have not had a cold sore develop as my dr told me to take Valtrex, I have taken one pill of that on 5/24. I also have taken Tylenol on 5/20, 5/21, 5/22 - 500mg 2 times a day.

Reported throat feeling "funny" and "hoarse" approximately five to six minutes post vac. Observed pt x 51 minutes. No SOB, tachycardia, tachypnea, wheezing, hives, cyanosis observed. Vitals WNL x 2. BP 118/80, Resp 16-18, Pulse 80-88. A/O x3. Over the 51 minutes feeling in throat improved w/o intervention. Left w/o assistance and under no duress.

Patient reported dizziness, lightheadedness, ascending warmth/tingling, tunnel vision, and that she "couldn't feel her hands" shortly after receiving her vaccine. She was highly anxious and stated "I never should have done this". On arrival to med obvs, her hands were in a contracted position and her arms/legs were shaking. Patient repeatedly asked if she was going to be paralyzed. The patient began to feel better after several deep, relaxed breaths. Patient was given water, apple juice, and crackers. Pt requested to use the restroom around 11:10. She was transferred there via wheelchair where she was able to urinate, and reported feeling better after doing so. On discharge, patient reported slight light headedness and "off" feeling, but was otherwise better. Vitals as follows: 10:50- BP 151/84, HR 144, RR 22, O2 97 10:52- BP 146/78, HR 144, RR 22, O2 97 11:00- BP 148/85, HR 125, RR 20, O2 100 11:07- BP 139/78, HR 116, RR 20, O2 100 11:26 (sitting)- BP 135/70, HR 104, RR 18, O2 100 11:36 (sitting)- BP 128/73, HR 98, RR 18, O2 100

R jaw pain maxillary/mandibular with mouth symptoms in neuropathic pattern similar to V2/V3 trigeminal distribution, low concern for CNS event, saw urgent care, dentist, periodontist, PCP x 2, scheduled to see ENT; symptoms improving somewhat, supportive care with viscous lidocaine, ice/heat, APAP/NSAIDs

My vision became abnormal the following day after receiving vaccine. I could see fine, but felt like both eyes were not in sync with one another. It comes and goes. It can last for hours at a time. It has been ongoing, everyday for 4 weeks. I have never had any vision issues prior to the vaccine. I have seen an optometrist and eye specialists. So far, they have seen no signs or not detecting any eye condition or problem. I am to follow up with the eye specialists in 5 weeks. They recommended giving it a few extra weeks to see if symptoms improved or went away before looking into further/other testing.

05/21/2021 Routine Covid-19 screening. later developed fever (subjective), cough, sore throat, shortness of breath, Chills, headache, muscle aches, lost taste and smell, diarrhea and later developed chest congestion.

Pt states that she lost taste and smell since her first dose and it has only intermittently recovered. For example, ranch now burns her tongue.

5/3/21-Contacted by individual to report that she has tested positive for COVID-19 test result with the following symptoms: cough, chills, headache, sore scratchy throat, congestion, runny nose, loss of smell, and fatigue. She has been Vaccinated x 2 with Pfizer COVID vaccine and denies any chronic conditions or medications.

Hives all over my body; Swollen eyes; Swollen knees elbows; Chills; This is a spontaneous report from a contactable Other Health Professional. A 41-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9266, expiry date was not reported), dose 2 via an unspecified route of administration, administered in Arm Right on 22Feb2021 14:30, 2ND DOSE, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had no allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior vaccination and since the vaccination. Historical vaccine includes BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9264, expiry date was not reported), dose 1 via an unspecified route of administration, administered in Arm Right on 31Jan2021 13.00, Single for COVID-19 immunization. The patient experienced Hives all over my body, swollen eyes, swollen knees elbows, chills on 22Feb2021 14:30. Patient was treated with Dosepk 4 MG. Adverse events resulted in Emergency room/department or urgent care. The clinical outcome of the events were not recovered.

Hearing go out and tinnitus in one ear intermittently for 2 weeks; Hearing go out and tinnitus in one ear intermittently for 2 weeks; Muscle jerking in arm, stomach, and one toe; Headache; This is a spontaneous report from a contactable other health care professional (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ER8731), via an unspecified route of administration in the left arm on 10Apr2021 at 00:00 (at the age of 41-years-old), 1st dose, single, for COVID-19 immunization. The patient had no medical history. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19 and did not receive other vaccines four weeks prior. The patient was not pregnant at the time of vaccination. The vaccine was administered at hospital. On 11Apr2021 at 13:00, the patient experienced hearing went out, tinnitus in one ear intermittently for two weeks; muscle jerking in arm, stomach, and in one toe and headache. The patient underwent lab tests and procedures which included nasal swab COVID-SARS PCR test: negative on 21Apr2021. The events were reported as non-serious. No treatment was received for the events. The outcome of the events was recovered on an unspecified date.

5/19-injection site pain, muscle aches, sore throat, (Tylenol taken every four hours) 5/20-injection site pain, muscle aches (Tylenol administered every 4 hours) 5/21- sore throat, muscle aches, low grade fever, (Tylenol taken every 4 hours) 5/22- extreme sore throat (burning sensation), ear ache, cough, headache, low grade fever, lost voice,(Tylenol taken, hot tea, throat lozenges, gargle with warm salt water) 5/23-sore throat, headache, cough,(Tylenol taken, hot tea, throat lozenges, gargle with warm salt water)5/24- sore throat, runny nose, cough, facial pain, ear ache, voice returned,(Tylenol taken, hot tea, throat lozenges, gargle with warm salt water) 5/25- persistent cough, runny nose, 5/26-dry cough, 5/27- dry cough, 5/28-dry cough, I am currently having coughing uncontrolled dry coughing fits which last a few minutes in duration.

Recurring pain around left eye. Probably sinus pain or migraine rather than true eye pain. Maybe be related to the walk to and from the clinic, exposure to strobe lights en route, etc.

throat felt like she had been talking all day and swollen; felt that they were giving a shot; couldn't get a full breath; right side of her face drooped a little; tongue was swelling; face, lips, eyelids and around them were swollen; intermittent chest pain; heart it felt achy at times; had a head rush; felt very hot suddenly; her ear started ringing and buzzing; she could not hear well; she felt immediately as if someone was trying to put her to sleep; She felt heaviness in her body, and in her chest and said it felt as if someone was lying on top of her.; her nose and mouth started to become gray and blue in color; numbness in her left arm; face, lips, eyelids and around them were swollen; face, lips, eyelids and around them were swollen; couldn't get a full breath because of the heaviness on her chest; fingers stay cold a lot; This is a spontaneous report received from a contactable consumer. This 41-year old female consumer (patient) received BNT162B2 dose 1 via an unspecified route of administration, administered in Arm Right on 06May2021 (Batch/Lot Number: ER8730) as 1ST DOSE, SINGLE for covid-19 immunization. Medical history included allergic to shellfish and almonds from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced a head rush after the first dose of the Pfizer-BioNTech Covid-19 Vaccine and felt that they were giving a shot . Everything was normal but when she came home, within an hour and 20 minutes, she suddenly felt very hot, her ear started ringing and buzzing, and she could not hear well. She said she felt as if someone was trying to put her to sleep. When the caller went to wash her face, she noticed her face, lips, eyelids and around them were swollen. The right side of her face drooped a little, it looked different on the jaw than the other side. The caller's tongue was swelling and her throat felt like she had been talking all day and swollen. She felt heaviness in her body like a weighted blanket and in her chest and said it felt as if someone was lying on top of her, it was like she couldn't get a full breath because of the heaviness on her chest. She also noticed that her nose and mouth started to become gray and blue in color but she could still swallow. She also had residual symptoms such as numbness in her left arm , it,feels like its asleep and intermittent chest pain like her heart it felt achy at times. This has gone away but it would come and go and feel like it was lightning, like thunder in her chest. Her fingers stay cold to the touch a lot from where they bend down to the tips more on her left than anything. She did not take herself to the emergency room or the doctor for the events. The caller didn't seek medical care because she had some medications at home that were for allergies from her allergist and it helped with the swelling. The patient reported the medicine was a powder tablet that is dissolvable, unknown name, she thinks she may have used it once, it has numbers on it. The swelling went down to where she felt like she was fine after taking them. The swelling in her face and her eye lids were puffy for a few days. The patient had blood work done the day of the vaccine, prior to receiving the vaccine and an electrocardiogram (EKG). Therapeutic measures were taken as a result of throat felt like she had been talking all day and swollen, tongue was swelling, face, lips, eyelids and around them were swollen, face, lips, eyelids and around them were swollen, face, lips, eyelids and around them were swollen. The outcome of right side of her face drooped a little was unknown, recovered from head rush, felt very hot suddenly, ears started ringing buzzing, couldn't hear well, trying to put her to sleep, face was pounding, face, lips, eyelids and around them were swollen, tongue was swelling, felt like something was heavy on her body, heaviness on her chest, blue and gray around her nose and mouth, chest was hurting, trying to put her to sleep, and felt that they were giving a shot on 06May2021, recovered on 09May2021 from face, lips, eyelids and around them were swollen, recovered on 10May2021 from chest was hurting and recovering from fingers stay cold a lot and numbness in her left arm. No follow-up attempts are needed. No further information is expected.

Heavy period Trouble with vision Eyelids swollen Erratic Heart rate Blood pressure Shaking Throat swelling Tingling in feet/hands No appetite Weight loss Pressure on chest Cough Ulcers in mouth Neuropathy These symptoms have been going on and have not let up. Currently on Lyrica .

Chills, night sweats, fever of 103.5, brown urine, body aches, shortness of breath, rapid heart rate, eye twitching

Vision blurriness 15 minutes later, subjective throat tightness 3 hours later, gone by next day. no symptoms with second dose.

The day after I received dose 2, 04/13/2021, I started having pain behind my eyes. I was feeling very fatigued. I had to take painkillers to help get through the day. I had a lasting headache for a whole week. My right armpit became swollen and sore. On 04/15/2021, I felt tingling on the left side of my body with mild dizziness and anxiety. I had a virtual visit with Dr. on 04/16/2021. I also had knee pain which is unusual for me. During my virtual visit, Dr. informed me that she felt fatigue for the week after she received her vaccine too. I was told that if my symptoms continue to follow up with the doctor. As of today, 06/01/2021, I can still see where I received the vaccination. I have a red bump there. It does not hurt, but it is noticeable.

Immediately developed a metallic taste in her mouth that lasted for 4 days. Within 15-20 minutes of receiving vaccine she developed tingling of her face and numbness of her tongue - this persisted for 10-15 minutes. She reports feeling drunk and disoriented for 3-4 days after vaccination.

She got her vaccine, she had no reactions at all. On 5/12/21, she woke up 2 days with ankle and feet swelling, hand and face swelling, eyelid swelling. She had a fever up to 100.5. Her swelling has not gone down on any of the locations. She cannot even take her wedding bands off. Her feet are extremely cramped in her shoes. Her allergies have gone tremendously. She has been throwing up and have been nauseous a lot. She has not been taking anything but Benadryl for the reactions. She also has gained 7# since the vaccine. Her hands have also been shaky. She has not notified her doctor of any of these symptoms.

Tinnitus - constant ringing in both ears; This is a spontaneous report from a non-contactable consumer (patient). A 41-year-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration in the left arm on 03Apr2021 13:00 (Lot Number: EW0151) as 1st dose, single dose for covid-19 immunization. The patient has no medical history. The patient was not diagnosed with COVID-19 prior to vaccination The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the most recent COVID-19 vaccine in a hospital. The patient experienced tinnitus - constant ringing in both ears which started within about a week of injection (09Apr2021) and has been going on for 7 weeks. The adverse event result in doctor or other healthcare professional office/clinic visit and the event was considered serious with seriousness criteria of disability. The patient has not been tested for COVID-19 since the vaccination. The patient did not received treatment. The outcome of the events was not recovered. No follow-up attempts are possible, information on the lot/batch number cannot be request. No further information is expected.

Loss of taste; This is a spontaneous report from a contactable consumer (patient herself). A 41-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unspecified date (at the age of 41-years-old) as SINGLE DOSE for covid-19 immunisation. Medical history included known allergies to sulfa. The patients concomitant medications were not reported. The patient previously took Zithromax and experienced drug allergy. The patient did not receive other vaccine in four weeks of vaccination. The patient was not diagnosed with COVID-19 prior vaccination. It was unknown if the patient has been tested for COVID-19 post vaccination. On 05Mar2021 at 07:00, the patient experienced loss of taste and no treatment was received for adverse event. The outcome of the event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

I got my second shot on 1/27/21, woke up Thursday morning and told my husband my tongue felt funny like it was numb. On Friday 1/29/21 went to work and as the day progressed I noticed it was difficult to eat lunch and then went home and noticed drooping of have my face. I called my employer and PCP, they told me to go to urgent care. They diagnosed me with Bells Palsy and prescribed and antiviral and steroid. I had a follow up with my PCP. It took about 3 weeks before my face returned to normal.

Swollen up lip; Very light chest tightening; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number: Unknown) via an unspecified route of administration in the left arm on 18Mar2021 at 14:00, (at age of 41-year-old) as a single dose for COVID-19 immunisation. The patient medical history included high blood pressure and pulmonary hypertension due to left heart disease. The patient was allergic to garlic. Concomitant medication included Atorvastatin (MANUFACTURER UNKNOWN), Lisinopril (MANUFACTURER UNKNOWN), vitamin-D (MANUFACTURER UNKNOWN), Iron (MANUFACTURER UNKNOWN), and Q10 for an unspecified indication from an unspecified date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 18Mar2021 14:00, patient experienced swollen up lip for 10 mins and very light chest tightening. The patient did not receive any treatment for the events. The clinical outcome of the event swollen up lip recovered on 18Mar2021 14:10 and the event very light chest tightening was recovered on an unspecified date in Mar2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

metallic taste in her mouth; lightheadedness; headache; nausea; tingling lips; This is a spontaneous report received from a non-contactable health care professional (HCP). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6205), on unspecified date (at the age of 41-year-old) as 1st dose, single for COVID-19 immunisation. The patient's medical history included that patient mentioned having a history of anxiety and she took her duloxetine and WELLBUTRIN the day of the present report (05Mar2021). The patient's concomitant medications included duloxetine and bupropion hydrochloride (WELLBUTRIN), both from unspecified date for anxiety. She denied use of her lorazepam (ATIVAN) recently. It was reported that during her 15 minutes waiting period after the injection, the patient began to experience lightheadedness, headache, nausea, tingling lips and a metallic taste in her mouth. She denied rash, difficulty breathing, difficulty swallowing, throat tightness, facial swelling and lip swelling. Treatment included paracetamol (TYLENOL) and water. Response to treatment was good. She noted some lightheadedness prior to discharge but other symptoms were improved. Reporter walked patient around the bay area and she was feeling okay. Her vitals were stable. Patient was escorted out of the facility. As per patient discharge it was reported stable to go home and follow-up with primary care physician (PCP). The outcome of the events was resolved. No follow-up attempts are possible. No further information is expected.

Onset of dizziness and mild nausea shortly after her shot. Near syncope described by patient with blurry vision briefly. Multiple prior V-V events including syncope described by her. No allergic type symptoms. BP, Pulse, O2 sat OK throughout 28 minute stay. Symptoms improved when supine and resolved on their own with time. No orthostasis.

Missed dose of the Vaccine; shingles on her face including around the eyes; Shingles, rash, on her face, on her eyebrow near her; Ear bothering her; Persistent headaches; This is a spontaneous report from a contactable consumer. A 41-years-old female patient received first dose of bnt162b2, (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot: number EN6207), via an unspecified route of administration, administered in Arm Left on 17Mar2021 as 1st dose, single dose for covid-19 immunization. The patient did not had any medical history. Concomitant medication(s) included vitamins nos (MULTIVITAMIN [VITAMINS NOS]) started taking about 5 years ago for good health, prenatal and general women's health vitamin. There was no prior Vaccinations within 4 weeks.On 01Apr2021, in the morning patient experienced persistent headaches, on 03Apr2021, early evening around 5 or 6 PM patient had ear issue started, ear started bothering her the pain started, patient thought she had an ear infection or something. On 06Apr2021, when patient woke up in the morning she had Shingles, rash, on her face, on her eyebrow near her eye. It was reported that patient got first Pfizer covid-19 vaccine injection on 17Mar2021 but then developed shingles 2 weeks later. She was wondering when she can get second injection, It has been about 7 weeks since the first. She had blisters that opened and then they scabbed. They are not visible but, she can still see what is left of them. It was a week or two ago they started to go away she believes. She went to Urgent Care and received an antiviral as treatment and was prescribed Valtrex as treatment and she is finished taking Valtrex. The eye doctor she went to see since she had the shingles on her face including around the eyes, told her to wait about 2-3 months to give her body time to heal and her immune system strong again before receiving her second Pfizer covid-19 injection. The patient reported that she needs to make a decision on whether she should get the next dose or not. The outcome of the event ear bothering her was resolved on 10Apr2021, persistent headaches resolved on 14Apr202 and event shingles on her face including, shingles, rash, on her face, on her eyebrow near her resolved on 21Apr2021 and outcome for missed dose of the vaccine was unknown. No follow-up attempts are needed. No further information is expected.

Patient was given the first Pfizer COVID19 vaccine around 5:36pm. While waiting her 15 minutes patient states that she is itchy, has blotchy skin, swelling in her feet and hands, and tingling in her face and lips. She is immediately brought back into theimmunization room for observation. Patient declined ice pack. After no signs of anaphylaxis and since patient was conscious and coherent, gave 25mg of diphenhydramine around 6:00pm. Told patient to remain seated for observation. Checked patient's bloodpressure at 6:12pm and it was 144/96 with pulse of 90. Patient states her blood pressure normally runs below 120/80. Brought patient back into immunization room for more monitoring. Patient states that symptoms are not improving. Recheck blood pressure at approximately 6:25pm and it was still elevated at 151/86 with pulse of 96. Patient declined ambulance ride and wanted to continue to be observed at the pharmacy. Continued to monitor patient and call pharmacy manager and market manager. Patient states that she has taken Benadryl and Zyrtec in the past for a previous allergic reaction and it did not lessen the symptoms. Discussed taking hydroxyzine and went over possible adverse reactions especially extreme drowsiness before giving to patient. Patient's husband was with her and would be driving her home. Gave hydroxyzine hcl 25mg approximately at 7:25pm and observed patient for additional 15 minutes. Patient felt comfortable enough to leave and go home with her husband. She stated that she has an epi pen and blood pressure monitor at her house and will continue to monitor symptoms and her blood pressure. Agreed if worsening symptoms to seek medical attention. Patient left pharmacy approximately at 7:40pm.

Coughing, sneezing, runny nose, congested, bodyaches, teeth pain, jaw pain, neck pain, headache, chest pain, fever, chills/sweats, loss of appetite, fatigue????, sore throat, painful swallowing? All symptoms started approximately five hours after receiving the vaccine, after receiving the vaccine within seconds I got incredibly lightheaded and dizzy, almost like a drunk feeling?

Immediately: headache, feeling off/loopy, mild shortness of breath 45 min later: dry mouth, tongue swelling, mild fatigue, sinus pressure , shortness of breath 1 day later: redness injection site, moderate swelling or arm, mild head cold 2 days later: mild fatigue, sinus pressure, pain arm and redness of injection site

Left sided hearing loss; This is a spontaneous report from a contactable physician who was also the patient. A 42-year-old non-pregnant female patient received bnt162b2, lot number and expiration date were unknown, via an unspecified route of administration on 16Dec2020 , 8:30 at a single dose for covid-19 immunization. The patient's medical history included antiphospholipid antibody from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 22Dec2020, the patient experienced left sided hearing loss. It was unknown if patient received treatment for the event. The outcome of the event was not recovered. The patient was not diagnosed with COVID prior to vaccination and has not been tested for COVID-19 since vaccination. Patient has no allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Information on the lot/batch number has been requested.; Sender's Comments: As an individual case report there is not enough evidence to establish a causal relationship with the suspect vaccine. Currently there is no clear biological plausibility between the vaccine use and the even onset. More information such as complete medical history and concomitant medications are needed for fully medical assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Got vaccine on 12-29 @ 9:40 , same day around 8pm had a rash with bumps from back of right arm down to wrist with little bumps, really red...had on left arm as well. next day on 12- 30 around 1:30pm co worker told me my neck was really red. I told her I was just hot from working, but by 3pm I had bumps, itchy, big raised red spots....right side was worse then left side but it did cross my whole neck. my arms cleared up but when I get hot it comes out enough to see where it was located. on sat Jan 2nd the bottom of my right ear swelled and had like a white like bump....but, as soon as I cooled off because I was hot it totally went away. today is Mon Jan 4th and my neck looks like the bad rash area has burned into my neck....I have been taking Benadryl crème on neck and Friday Dec 1st I started Benadryl pills but stop taking pills after sat Jan 2nd because I was just to tired.

began to feel foggy/slow, arm too paintful to move within two hours and by 11:20 my tongue I had finally noticed was swollen. EMS was called and I was sent to the ER.I was given benedryll by ems, at ER I was given a steroid, Claritin and another medication for the reaction. Discharged with epi pens, a round of steroids, benedryl initially which was changed to Claritin by follow up dr.

Loss of sense of smell, no other COVID symptoms; This is a spontaneous report from a non-contactable other healthcare professional. A 42-year-old female patient started to received first dose of BNT162B2, intramuscular (left arm), on 17Dec2020 14:00, at a single dose, for COVID-19 vaccination. The patient had no relevant medical history and was not taking concomitant medications. On 25Dec2020, the patient had loss of sense of smell; no other COVID symptoms. Outcome of the event was not recovered. No follow-up attempts are possible. Information on lot/batch cannot be obtained. No further information is expected.

had loss of sense of smell and tested positive for the virus; had loss of sense of smell and tested positive for the virus; This is a spontaneous report from a contactable healthcare professional (patient). A 42-years-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), intramuscular on 17Dec2020 at a single dose on the left arm, for Covid-19 immunization. The patient has no medical history and no concomitant medications (no other vaccines in four weeks and no other medications in two weeks prior to vaccination). The patient has no known allergies to medications, food, or other products. The patient had loss of sense of smell, no other symptoms on 25Dec2020 and tested positive for the virus yesterday, on 27Dec2020. The patient has no Covid-19 prior to vaccination. The patient underwent Covid test (Nasal Swab) and result was positive on 27Dec2020. The patient did not receive any treatment for the event. Outcome of the event was unknown. The events were assessed as non-serious by the reporter. No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Sender's Comments: A possible contributory role of BNT162B2 vaccine cannot be excluded for event based on available information.

Severe left arm pain; loss/dulling of taste within 1hr of vaccine that lasted 12hrs; loss/dulling of taste within 1hr of vaccine that lasted 12hrs; joint pain; tiredness; This is a spontaneous report from a contactable nurse (patient). A 42-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EH9899), via an unspecified route of administration in left arm on 17Dec2020 07:45 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. There was no medical history. Concomitant medication in two weeks included vitamin d3, cyanocobalamin (B12). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe left arm pain; loss/dulling of taste within 1hr of vaccine that lasted 12hrs; joint pain and tiredness on 17Dec2020 at time of 09:00 AM. No treatment received for these events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of events was recovered in Dec2020.

throat feeling "hot"; tongue feeling numb and thick; tongue feeling numb and thick; This is a spontaneous report from a contactable nurse. A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL1284, expiry date unknown) intramuscular at left deltoid on 28Dec2020 10:00 at single dose for Covid-19 immunization. The COVID-19 vaccine was administered in the workplace clinic. Medical history included allergies to shellfish, allergies to strawberries, and environmental allergies. Concomitant medications were not reported. On 28Dec2020 10:30 am (approximately 30 min post vaccine), the patient experienced that her throat feeling "hot" and her tongue feeling numb and thick. The patient denied ever feeling short of breath. The patient's vital signs were recorded on 28Dec2020. The patient was not tested for COVID-19 since vaccination. The outcome of the events throat feeling "hot", tongue feeling numb and thick was unknown. The reporter considered the events non-serious; did not results in death, was not life threatening, did not caused/prolonged hospitalization, was not disabling/incapacitating, not a congenital anomaly/birth defect.

arm pain all the way down to fingers unable to lift arm past head dizzy weak headache nausea chills no fever exhausted no appetite arm pain is 60% better today no redness at injection site mild swelling at injection site mentally foggy weak vision

had swelling of mouth, flushed face, treated with 50mg of diphenhydramine. symptoms resolved within one hour

she could barely walk/couldn't walk hardly; feeling cruddy/doesn't feel good at all; She slept from the time she got home, all night. and part of day today; this was the first dose which is a half dose that they had to split the one dose into two because it was too powerful for one dose; running a fever; Fatigue/she is tired again; very weak; nauseated; Headache; Her throat didn't feel right; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 29Dec2020 at half dose, single for covid-19 immunization. The patient's medical history was not reported. There were no concomitant medications. It was reported that the patient previously received INFLUENZA VACCINE for immunization but she gets nauseated and tired. On 29Dec2020, she was very weak, nauseated, had a headache, fatigue and her throat didn't feel right. On 30Dec2020, she was running a fever, it was 100.5 (units unspecified). It was also reported that she could barely walk; further reported as couldn't walk hardly, she was still feeling "cruddy" and she just doesn't feel good at all. The patient reportedly slept from the time she got home, all night and part of day today. After she rests for a while, once she gets up, she is tired again. It was also reported that the patient was told that this was the first dose which is a half dose that they had to split the one dose into two because it was too powerful for one dose. She will receive her second dose on 19Jan2021. Outcome of the events "very weak" and "fatigue/she is tired again" was recovering; outcome of events "nauseated", "headache", "her throat didn't feel right" and "running a fever" was not recovered; outcome of the events "could barely walk/couldn't walk hardly", "feeling cruddy/doesn't feel good at all" and "slept from the time she got home, all night and part of day today" was unknown. Information about lot/batch number has been requested.

At 3:30 am 1/7/2021 I woke up to my whole body head to toe covered in hives/rash and my lips were swelling. I took 2 Benadryl and slept. At 6 am lip swelling went down but hives are all over still. At 8 am I took another Benadryl. It is now 12:30 and still there and itching.

Roughly 12 hours after receiving dose number 2, I started to have body aches, general malaise, a headache, eye pane, and left ear pain. Around midnight, I started to experience severe chills along with the body aches. I woke up around 4:30 a.m. with a fever, 38.8?C orally. All other symptoms continued as well.

After receiving the vaccination, when I stood up I felt a rush to my head. I went to sit in the waiting area to be monitored and my tongue and lip started itching. I then started w/ a red rash to the R side of my neck. My body started to itch all over. I was brought into a treatment room and my vital signs were being taken when I started to have an increase in coughing, shortness of breath and vomiting. I was given an epipen and brought to the emergency room when I received Benadryl 50mg IV, Solumedrol 125mg IV, and Pepcid 20mg IV. Approximately 1 hour after receiving the medication my face again began to itch and I was given an additional dose of 25mg of Benadryl. My reaction resolved and I was discharged home with a prescription for prednisone.

Patient states she became hot and flushed about 2 minutes after receiving vaccine. The right side of her tongue became tingly. The rapid assessment team responded and noted her blood pressure was 186/103 and pulse was 146 and she had a headache. They had her rest for about 45 minutes and she felt better. Her blood pressure came down to 130/90 and pulse was 100. On 01/07/20 she still is experiencing a headache and body aches. She has never felt short of breath.

Palpitations. Tingling of lips. Presented to ED. Observed x 4 hours. Patient improved. Discharged to PCP if sxs worsen. ED notes incomplete.

Chills; Headache; Bad dreams; Excessive thirst; This is a spontaneous report from a contactable other hcp, the patient. This 42-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (lot number EL3246), intramuscularly on 02Jan2021 at 10:00 (at the age of 42-years-old) as a single dose for COVID-19 vaccination. Prior to the vaccination, the patient had been diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not pregnant at the time of vaccination. Concomitant medications were not reported. On 02Jan2021, the patient experienced headache, chills, bad dreams and excessive thirst. No therapeutic measures were taken as a result of the events. The clinical outcome of headache, chills, bad dreams and excessive thirst was not resolved. It was also reported that since the vaccination, the patient had not been tested for COVID-19.

recipient had a metallic taste in her mouth after vaccine administration, states this had happen before with other vaccines.

Received vaccine on 1/5, began having swelling in bilateral hands and lower extremities on 1/7, along with fatigue. On 1/8 she reports new swelling started in her face (eyes and cheeks). Swelling has not improved today and fatigue has worsened.

5 minutes following tingling in my lips and tongue. Later that night my tongue felt thick and the tingling progressed from the tip to the back of by tongue.

lient's tongue became swollen within 20 min. of vaccination. Swelling did not resolve by 4:00pm, client seen at urgent care. Client treated with Prednisone 60 mg PO x1; client prescribed Benadryl Q 4-6 hrs. x2 days, Prednisone 20 mg PO BID x5 days. Client developed generalized pruritis and lip tingling approximately 12 hrs. post-vaccination. Tongue swelling improved but not fully resolved at this writing (72 hrs. post-vaccination).

Within approximately 20 minutes of receiving the vaccine, numbness and tingling was felt in the face, burning of the eyes, and a metallic taste was noticed in the mouth. However, all of these sensations went away on their own within five minutes of onset, without any intervention.

1/8 - Within 12 hrs had body, eye, and headache. Overall tired. Could not do normal daily things without feeling wiped out . 3 Advil did nothing- sat 1/9. Next day felt better.- sun 1/10. That evening low grade fever 99.6 and achy again., mostly eyes and head. Went to bed. Monday okay. But noticed right armpit a pit puffy.- same side as injection. Tuesday 1/12 woke up at 6:00am and had dull joint/bone pain bilaterally. Ranging from neck ache, to sternum/upper back, shoulders, triceps. Injection site still sore- slightly red off to the side. Did some stretches in bed and eventually got up. I am very in tune with my body- something is off. I never wake up feeling ?bad?. Fit, healthy and active normally. Almost like a bad nights sleep with a poor mattress but only affected my upper body. Took two Advil and hot shower- feel better but can tell something doesn?t feel right.

While patient was receiving her second dose of the Pfizer brand Covid-19 vaccination (at 14:50), she mentioned to me that she had a sustained local reaction to her first dose. Her arm had a hard, red, hot spot for approximately a week. At this time I told her we would like her to stay under observation for 30 Min instead of the normal 15 min. At approximately 25 min post vaccination, the pt reported the following: "arm felt heavy, both arms did, but more so the affected arm, instant headache, sore neck, vision went fuzzy, breathing wasn't difficult but felt labored, throat felt like it was closing/congested, rash on the inside of the affected arm".   Pt stated that her heart felt like it was "pounding".   VS: 162/96, 99% RA, HR in the 70's.   Patient was administered 50ml IM diphenhydramine and monitored for 90 minutes in the clinic area. Dr. was consulted and also spoke with the pt, advising her to continue with OTC diphenhydramine once at home.   The symptoms resolved after approximately 40 minutes. By 17:00 the patient was deemed stable to go home with the instructions to go immediately to ED should any further Sx present. It was verified that she did not live alone and would have someone with her that could assist.   Pt was subsequently followed up with a phone call on the next day by RN who relayed that she was very tired, but no other complications.  

1/8/21 - An hour after receiving the vaccine I experience a metal taste in my mouth that lasted throughout the day. 1/9/21 - I woke up at 4am the follow day after receiving the vaccine and my left side of my face was numb, I could still taste metal in my mouth, I had a headache and pain in my right arm. I watch my symptoms and checked to see if I was having a stroke, but nothing pointed to that. 1/10/21 - I still was experiencing the same symptoms from 1/9/21 with not increased or decreasing of symptoms. Watched them throughout the day but nothing changed. 1/11/21 - I continued to have the same symptoms and reported to the ED after work for the symptoms listed above with no improvement. 1/12 & 1/13 - I continue to have the same symptoms with no changes.

1st injection on 12/20/20 with side effects of sore R arm and pain/stiffness at R hand for about 24 hours. After 2nd injection on 1/10/21, I had soreness at R arm, fatigue on first day. 2 days after 2nd injection, I developed rash/swelling around both eyes, and on 3rd day had worse eye symptoms and rash across upper chest. I called employee health and my PCP to report symptoms.

2230 feeling of unease, body aches, site arm tingling, general mild aches 0220 awoke from sleep choking, having difficulty breathing, felt very SOB, worse with exertion or trying to speak, great difficulty swallowing and speaking even in brief words. Took 50mg of Benadryl PO and went to the ED, about a 15 minute car ride. Had tingling and numbness of the tongue and back of throat by arrival but still able to breath with focus. Exertion of just walking into the ED greatly increased the SOB. Was triaged, Benadryl starting to help, was able to speak a little better, 3-4 words without too much SOB caused. Was walked to a room, SOB milder with that exertion. Seen by Dr. Given IV Sol-u-Medrol and 50mg Benadryl. Was observed on cardiac monitor/Q15VS for a few hours and discharged home around 5:30. Given Rx of Prednisone 20mg -3tabs x2 days, 2tabs x5 days all once a days and told to take 50mg of Benadryl Q4H for the next 24 hours at least and to return prn. I did need to stay on Benadryl, as the Sol-u-Medrol wore off some of the swelling in thr throat did return but not severe, Benadryl did help, along with taking my Asthmnex I already had. I also continued my normal HS antihistamines. I had SOB on exertion, progressively better from the 6th-10th with it mostly resolved to yesterday. Body aches have continued but also progressively better. Yeasterday1/12/21 the Rx of prednisone was completed and I did have some mild swelling /tingling in the throat/face/mouth return in the evening, took Benadryl 50mg again and inhaler used. I have an appointment today to seek further care at my primary doctor's office. Asthmnax used again this morning as well, only mild tightness in the throat currently with mild body aches this whole time.

patient experienced transient tingling of lips shortly after vaccine administration (within 15 minutes but could not specify exact time after). Symptoms resolved on its own within 10 minutes of reporting to us (pharmacists). Declined oral diphenhydramine at time of reporting to us but said she would let us know if she had any changes. No further adverse events or symptoms returning >2 hours after initial report.

Patient initially experienced tingling in left hand right after injection. This resolved but then she began to have tingling in her lips. Then she had tingling at the tip of her tongue and then her neck began to feel stiff. Her blood pressure also rose to 145/72. Her baseline BP is usually 96/69. She was administered 02.ml epinephrine subcutaneously, Then when her lip tingling did not resolve, Benadryl 50mg IM injection was given. After 2 hours of observation, her symptoms resolved and she was released to go home. No ER visit was necessary.

Tingling of the tongue, heaviness began at 13:30 p.m., 50 mg Benadryl given at 13:35, BP 110/70, BPM-108 14:00 p.m. symptoms continuing, symptom improvement beginning at 13:00 p.m.

The dat after the second dose just before noon I suddenly had eye floaties in my right eye. Unlike a usual floatie that might come and go these have a shape that changes as I move my eye. There is no pain, they are a sudden annoyance that i hope will go away but I wanted to make sure I reported it.

1700 felt increase in HR (120), warm feeling, B/P 132/80 Upper chest and facial cheeks along with ears flushed 1715 nausea, no vomiting, light headedness, mouth dry, tolerated apple jice and crackers 1830 felt normal

Extreme Headache; chills; sore throat; water eyes; runny nose; tiredness; entire body aches; This is a spontaneous report from a contactable Nurse reporting for herself. A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular at left arm on 06Jan2021 14:45 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Nursing Home/Senior Living Facility. Medical history included prior to vaccination, the patient was diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced extreme Headache, chills, sore throat, water eyes, runny nose, tiredness entire body aches on 07Jan2021. No treatment was received for the events. Since the vaccination, the patient has been tested for COVID-19, the patient underwent lab tests and procedures which included Covid-19 test/Nasal Swab: negative on 05Jan2021. The outcome of the events was unknown. Information about lot/batch number has been requested.

My lip felt sore and swollen. I looked in the mirror and it?s moderately swollen. I had filler in my lips 2 years ago.

Received 1st pfizer vaccine by IM at 10:00am on her left arm and felt throat soreness at 10:15am and needs to tilt head up. Advised patient to sit under observation. At 11am continues to have throat soreness and light shortness of breath. Continues to need to tilt head up. Light tingling around throat. Has never felt this before. No dermatologic symptoms. Moved her for observation at ED at 11:30am

5 min after vaccine administration, developed 3 pre-syncopal episodes and low blood pressure. Continued with paresthesias in lips, mouth, tongue, finger, legs, and toes. 2-3 hours after administration developed lip, face and tongue swelling. Administered Zyrtec and tylenol. Symptoms improved but continued into next day. 18 hours after administering vaccine developed rigors, fever (Tmax 103), severe myalgias, fatigue, nausea, vomiting, diarrhea, abdominal cramping. These symptoms persisted for another 12 hours. Tylenol was given to assist fever and pain.

After 5 min following administration, developed low blood pressure and 3 pre-syncopal events. Continued with paresthesias in lips, tongue, mouth, fingers, legs, and toes. 2-3 hours after administration, developed lip swelling, facial swelling, and swelling of tongue. Zyrtec and tylenol were given. This improved but was still present the next day. At 18 hours following administration, developed rigors, fevers (Tmax 103), severe myalgias, nausea, vomiting, diarrhea, and abdominal pain. These persisted for another 18 hours.

On 1/15/21, the day of the shot I had slight nausea, a sore arm around the injection site and fatigue in the evening. On 1/16/21, day two I had nausea after eating breakfast, extreme fatigue, muscle aches and joint pain. I also had a sore throat and odd sour taste in the morning, both days following the shot. This morning, day 3 I feel tired with less aches.

Pt was given Pfizer vaccine dose #1 and patient's face became flushed within 1 minute of administration. Pt has hx of multiple allergies. Pt was asked to take mask off and redness subsided within 5 mins. Pt then reported having numbness/tingling in tongue and lips. Pt was monitored for a total of 36 minutes per RN. Pt reported no further symptoms and noted improvement of symptoms. She was discharged to home with husband, who was also present for the event.

About 20 minutes after Dose 1 of vaccine administration, pt developed urticaria to neck. Denies SOB, resp difficulty, swelling of oral mucosa. Visual inspection of upper torso and extremities, no further urticaria noted. 5 minutes later, urticaria more pronounced. Pt sent to convenient care. pt presented with hives in the neck, slightly itchy. Pt denies respiratory distress, swollen lips, swollen tongue. Pt does have a history of asthma and has been on prednisone many times. Pt had urticarial rash with erythematous patches on anterior chest that are blanchable. No welts anywhere. No rashes anywhere else. Pt was given diphenhyramine 25 mg IM x 1 and rash/itchiness started to get better. Pt discharged home with a prescription for prednisone 40 mg PO QD x 5 days and instructions to take diphenhydramine Q6h PRN. Pt already on loratadine. Pt instructed to f/u with PCP.

couldn't differentiate the tingling in hands and feet from shot or from that; sharp pain jolt behind eyes/eyes hurt; icreamed; Her hand eye coordination was off as well and she wasn't able to be accurate on keyboard and her cursive was off; Whole body still weak; sharp pain jolt behind eyes, left one in particular so bad she screamed and the nerves went all the way to finger tips; Twitching of face when do certain movements; brain zaps and brain buzzing began; numbness to right side of face to neck/made its way to left side; Horrible headache; fatigue; felt pressure behind her right eye; felt in a fog; forgetful mid conversation; This is a spontaneous report from a contactable other health professional (patient). A 42-year-old female patient (not pregnant at the time of vaccination) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, EL0140), intramuscular on 23Dec2020 08:00 at single dose at right arm for COVID-19 immunization; prednisone via an unspecified route of administration from an unspecified date to an unspecified date (for 4 days) at 50 mg for an unspecified indication. Medical history included Known allergis: latex, contrast dye. Concomitant medication included the first dose of influenza vaccine (FLU) on 30Nov2020 at single dose at right arm for immunization. Facility where the most recent COVID-19 vaccine was administered at Hospital. The patient received other vaccines within 4 weeks prior to the COVID vaccine. It was reported that Day 1: on 23Dec2020 08:15, the patient felt pressure behind her right eye after shot, felt in a fog, forgetful mid conversation. Day 2. (24Dec2020) Horrible headache started, fatigue. Day 3 (25Dec2020) brain zaps and brain buzzing began, headache, fatigue, numbness to right side of face to neck. By day 5 (27Dec2020) made its way to left side. Twitching of face when do certain movements. Her Dr gave her Prednisone and she took 50 mg for 4 days and stopped because she couldn't differentiate the tingling in hands and feet from shot or from that. Still brain zaps, newest issue sharp pain jolt behind eyes, left one in particular so bad she screamed and the nerves went all the way to finger tips. Her hand eye coordination was off as well and she wasn't able to be accurate on keyboard and her cursive was off. Whole body still weak, eyes hurt. Head a lot better than a day ago but still having buzzing and twitching. Today was day 18. She was awaiting an MRI with contrast on Friday hoping it got moved sooner as she was scared to what was going on. The adverse events result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment received for the adverse events included CT/MRI/Optic Nerve Scan/Pain Shot/Meds for Zaps. The events were non-serious per the reporter. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab tests and procedures which included Nasal Swab: negative on 28Dec2020. The action taken in response to the events for prednisone was permanently withdrawn on an unspecified date. The outcome of the events reported as not recovered.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of all these reported serious events might not be fully excluded, considering the plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

10:35a: COVID vaccine #1 Sitting in monitoring room. 11:05a: checked for symptoms and reports shortness of breath and wheezing. Has history of asthma and has albuterol with her. 11:08a: O2 100% RA, HR 116 Took albuterol inhaler x2 puffs Ongoing shortness of breath. Reports sharp pain in her chest. Reports dizziness. 11:10am BP: 110/84, O2 99%, HR 113. No wheezes on exam Drank fluids and given snack. Reports difficulty swallowing. Sharp pain in chest is worsening. Shortness of breath worsening. Reports nausea. 11:18a: glucose 178. HR 112, O2 100%. Ongoing sharp pain in chest and worsening shortness of breath 11:20a: Given Benadryl 25mg and orange juice. 11:30a: Requests to go to ER ? 911 was called. Repeats albuterol inhaler 11:40a Reports shortness of breath worsening and closing sensation in her throat. Burning sensation in her mouth. Chest pains worsening and ongoing dizziness. Given epipen 0.3mg [due to shortness of breath, sensation of throat closing, nausea, dizziness, tachycardia] 11:43a: EMS arrive, assess and transport to ER

Employee reported palpitations 5 minutes after vaccine was administered then began having rash on chest and tingling in lips and face. Benadryl 25mg and Epi-pen were administered. Symptoms got better and employee went home. Had to go back to Emergency Room for tingling all over and flushing to face.

Developed myalgias on 1/12 which lasted until Friday and developed loss of sense of smell and taste on Tuesday which lasted until Thursday

Body aches, joint pain, fever (tmax 101F), Mentally fog, fatigue Left sided Headache, dizziness, and I couldn?t hear out of my left ear. These symptoms peaked approximately 12 hours after the vaccine. They lasted for 24 hours. The next day, the fever was gone and the only symptom I had was fatigue. 48 hours after the vaccine all my symptoms had resolved.

mild redness; mild swelling; itchy; burning; swelling to the eye; mild rash around her left eye; This is a spontaneous report from a contactable nurse reported for herself. This 42-year-old female patient (No pregnant) received the second dose of the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an 08Jan2021, 10:45 AM on Right arm at single dose for covid-19 immunisation. Medical history included juvaderm under her eye approximately 1 year and half to two years ago. Prior to vaccination, the patient did not diagnose with COVID-19. No Allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at age of 42-year-old on an 18Dec2020, 11:15 AM on Right arm at single dose for covid-19 immunisation. Day after the 2nd dose, the patient had a mild rash around her left eye only on 09Jan2021. 3rd day (11Jan2021) swelling to the eye. The day of this report is 4 days post vaccine (12Jan2021), the patient mild redness mild swelling but remain itchy and burning. The patient did not report to her dr as the symptoms seem to be resolving on its own. No covid tested post vaccination. No treatments were received. Outcome of the events was recovering. Information on the lot/batch number has been requested.

EE statement "I was given the COVID vaccine on Friday Jan 8th at around 12:30 pm. I starting tasting metal in my mouth about an hour after the vaccine was given. Saturday 1/9, I woke up at 4am with left sided face numbness from my forehead to the middle of my neck. I also had a headache and some right arm pain at the site of the vaccine. These symptoms continued through Monday 1/11 when I reported to the Emergency Room at. I had a CT scan completed and release with negative results. I had a COVID test completed on Tuesday 1/12. I had an MRI on Wed 1/13 with negative results. I seen my primary physician on Thursday 1/14 as a follow-up. I was informed that I had a reaction to the vaccine and that my symptoms would properly last for 2-3 weeks, marked as Bells Palsy and put on prednisone. Today, I still have some left face numbness and my taste is coming back."

Immediate arm and neck soreness/12 hours later joint pain , Back pain, muscle aches, headache, rapid heart rate, metallic taste in mouth. weakness, fatigue, Symptoms still current after 2 weeks post vaccine.

Migraine on day 3. Started around 5 pm the first time, took ibuprofen and hydroxyzine to sleep until it passed. Day 6, another migraine. Ibuprofen and caffeine. Day 7 I went to get a haircut thinking the migraines may be caused by heavy long hair. Day 8 extremely painful migraine, can?t open eyes as light made it worse, nausea, vomiting. Called my PCP, they recommended going to urgent care after I vomited. I couldn?t get a ride so I took ibuprofen, Tylenol, and hydroxyzine to help me sleep until it?s gone.

5 mins: mild site itching 15mins: whole body itching mod 20 mins: tongue swelling, coughing 25 mins: difficulty swallowing, tight breathing Pt was given 2nd round of 25 mg benedryl, epinephrine, Prednisone, albuterol breathing treatment and monitored for 3 hours. Sent home on 5 day course or prednisone

About 20 min after receiving my Covid 19 vaccine, I left Hospital and began to feel numb in my throat, my lower face, and the tops of my shoulders. I had reduced sensation, but also felt as though I had no muscle control with movement. Examples of this are when I tried to flex my head forward as if in a nodding motion, or to elevate my shoulders like a shrug, or clench my jaw like when chewing. These were all extremely difficult and I felt as though I had no awareness of if I was even moving these parts of my body whatsoever when I tried to voluntarily do so. It was very strange and also upsetting. I also began to have blurred vision; it was difficult to focus or see properly, such as when you visit the eye doctor and they dilate your pupils and everything seems blurry and out of focus for a period of time afterwards. This all lasted for about exactly 1 hour post. I did not seek medical attention for this as it did not worsen. I never had any difficulty breathing. It then completely went away.

Headache with strobe light in periphery-left eye. Later, chills, body aches, slight nausea, fever of 101.2 at highest temp recorded. Started on 1/20 at around 9 pm. Symptoms subsided early morning of 1/22.

Bells Pallsey event Left arm, face, tongue numbness and tingling, slurred speech, no left facial movement Last approximately 1hr 1/2 then full function returned

Blurred vision, headache, disorientation, fatigue, chest pain, chest pressure, shortness of breath, severe muscle and joint pain, hypertension, tachycardia, severe skin sensitivity, abdominal epigastric pain and spasms, severe cough, dizziness, lightheadedness. Reaction symptoms were not all immediate and developed over next 3 days requiring evaluation and treatment in the ER. I required decadron injection to stop inflammatory response and was sent home on oral decadron. I am still experiencing symptoms but not as severe. I have to take my albuterol inhaler so I can breathe easier. My monocytes count was elevated.

I have been experiencing swollen lymph nodes in my neck and eye twitching since receiving the shot. My lymph nodes swelled almost immediately and the eye twitching started days later. I'm still experiencing them a week later.

Numbness to the left side of my face from the bottom of my eye to the middle of my neck; headache; metal taste in my mouth; some soreness at the site; diarrhea; This is a spontaneous report from a contactable Other HCP (patient). A 42-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), intramuscular in the right arm on 08Jan2021 12:30 at single dose for COVID-19 immunisation at doctor's office/urgent care. Medical history was none. Concomitant medication included losartan (unknown manufacturer). On 09Jan2021 at 04:00 the patient experienced numbness to the left side of her face from the bottom of her eye to the middle of her neck, headache, metal taste in her mouth, some soreness at the site and diarrhea with outcome of not recovered. The events resulted in Emergency room/department or urgent care visit. The patient underwent sars-cov-2 test: negative on 11Jan2021, and computerised tomogram and magnetic resonance imaging with unknown results on unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19.

left arm pain, sharp, stabbing, weak, painful to move.; increase ear and teeth pain including left jaw; face swelling including eyes; left ear and teeth pain; left ear and teeth pain; drooping of right side of face at mouth/neurology visit diagnosed with bells palsy reoccurrence related to vaccine; drooping of right side of face at mouth/neurology visit diagnosed with bells palsy reoccurrence related to vaccine; numbness/swelling to left side of face/some numbness and tingling intermittent left arm; numbness/swelling to left side of face; some numbness and tingling intermittent left arm; Left neck stiffnes and pain; Left neck stiffnes and pain; Left arm pain; Headache; This is a spontaneous report from a contactable nurse (patient). A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 15Dec2020 15:45 at left arm, at single dose for covid-19 immunization. Medical history included facial paralysis from 2010, ongoing chronic migraine, Known allergies was None. Concomitant medication included cetirizine hydrochloride (ZYRTEC ALLERGY); ibuprofen; paracetamol (TYLENOL); ascorbic acid, biotin, calcium pantothenate, cyanocobalamin, folic acid, nicotinic acid, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, tocopheryl acetate (MULTIVITAMIN). The patient was not pregnant at the time of vaccination. The patient experienced left arm pain day of vaccine lasting through the week from 23Dec2020 06:00. Headache everyday after. On 28Dec2020 the patient noted numbness/swelling to left side of face, some numbness and tingling intermittent left arm. Left neck stiffness and pain. On 31Dec2020 increased left neck pain 10/10 and noted drooping of right side of face at mouth, left ear and teeth pain. On 02Jan2021 face swelling including eyes, increase ear and teeth pain including left jaw. Headache and neck pain continued. On 05Jan2021 Virtual visit with NNP started AbX and steroids (possible bells palsy flair up) and dentist visit no issues with teeth. On 08Jan2021 neurology visit diagnosed with bells palsy reoccurrence related to vaccine. Throughout the week increased numbness, tingling, and pain to left arm. With intermittent sciatic type pain to left leg. her whole left side had felt different since the vaccine. Constant left arm numbness, tingling, and pain since 09Jan2021. Minimal relief from headaches pain from 8 to 5. On 13Jan2021 10/10 left arm pain, sharp, stabbing, weak, painful to move. Treatment Steroids, pain meds, and MRI scheduled were received. All events resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the event headache was recovering, the outcome of the other events was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Information about lot/batch number has been requested.; Sender's Comments: Based on the time association, the facial paralysis recurrence is possibly related to suspect BNT162b2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Exceptionally dry eyes; This is a spontaneous report received from a contactable other healthcare professional (who is also the patient). A 42-year-old female patient received the first dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246, expiry date: unknown), via an unspecified route of administration in the left arm, on 12Jan2021 08:30, at single dose, for COVID-19 immunization, in the hospital. There were not medical history and concomitant medications. The patient has no known allergies and is not pregnant. The patient did not have COVID-19 prior to vaccination. The patient did not receive other vaccines in four weeks. The patient experienced exceptionally dry eyes on 12Jan2021 at 20:30. Treatment included saline eye drops. The patient was not tested for COVID-19 post vaccination. The outcome of the event was recovered in Jan2021.

2 days after vaccine woke up with a fever of 102, severe headache, chills, eye pain upon movement, nausea--took until 1/22 to resolve

Headache on the left side, left sided ear, jaw and neck pain going on 4 days. Extreme fatigue going on 4 days.; Headache on the left side, left sided ear, jaw and neck pain going on 4 days. Extreme fatigue going on 4 days.; Headache on the left side, left sided ear, jaw and neck pain going on 4 days. Extreme fatigue going on 4 days.; Headache on the left side, left sided ear, jaw and neck pain going on 4 days. Extreme fatigue going on 4 days.; Headache on the left side, left sided ear, jaw and neck pain going on 4 days. Extreme fatigue going on 4 days.; This is a spontaneous report from a contactable nurse (patient). A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EL3248), via an unspecified route of administration in left arm on 08Jan2021 14:15 at a single dose for COVID-19 immunization. Medical history included migraines, anxiety, arthritis, EOE, IBS, asthma, possible autoimmune disorder AS, and known allergies with caffeine. Concomitant medications included topiramate (TOPAMAX), buspirone hydrochloride (BUSPAR), paracetamol (TYLENOL), montelukast sodium (SINGULAIR), and multivitamin. The patient previously took scopolamine allergies. The patient experienced headache on the left side, left sided ear, jaw and neck pain going on 4 days, extreme fatigue going on 4 days, since 08Jan2021 22:00. The event resulted in doctor or other healthcare professional office/clinic visit. The patient has no COVID prior vaccination, has not been tested for COVID post vaccination. Treatment for the events included MEDROL dose pack and TYLENOL. The outcome of the events was unknown.

1st 5 to 7 min dizziness, 10 to 15 min right tongue heaviness and left lower lip tingling, chest tightness. All mild symptoms. tongue and Lip Issues resolved in abt 1 hour and chest tightness in abt 2 hours.

Exhaustion Migraine Pain at injection site My lips went numb My hands went numb Nauseous I slept for 16 hours

Nausea; Fatigue; Muscle/joint aches; Muscle/joint aches; Unusually sour taste in saliva in the mornings; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 3302), via an unspecified route of administration on 15Jan2021 07:30 in Left arm at single dose at Workplace clinic for COVID-19 immunisation. Medical history included Rhinosinusitis, Thoracic Outlet Syndrome, Polycystic ovarian syndrome (irregular menstrual cycles) and CBC issues: low white blood cell count, low lymphocyte count, high MCV (Mean cell volume) (under current care), all from an unknown date. Concomitant medication included Multivit, ergocalciferol (VIT D), folic acid (FOLIC), fish oil, magnesium, biotin. There was no other vaccine in four weeks. The patient did not have COVID prior vaccination and not had COVID tested post vaccination. The patient experienced Nausea, fatigue, muscle/joint aches and unusually sour taste in saliva in the mornings on 15Jan2021 11:00. The patient did not receive treatment for the events. The outcome of the events was recovering.

c/o weird taste in mouth, warm, rash on chest and right deltoid around injection site only, pt given benadryl 25mg , water, and ice pack, waited 30 minutes, rash subsided and pt feeling ok

45 minutes after given the vaccine. Severe dizziness, stumbling, couldn't see straight, Had somewhat similar reaction to the first dose went down to the Emergency room on 12/31/20. They treated it as vertigo. gave zofran for nausea and valium to calm me down. Was sent home with Meclizine (motion sickness)meds. I am at 9 days after the vaccine administration and still having the vertigo and nausea due to being dizzy. I didn't go to the emergency room right away as I was treating it as they treated the first one. I fell asleep as soon as I got home from work at 130pm. I got the second dose at 0900 on 1/21/21. Fell asleep for several hours. Could barely wake up. Hands and feet were swollen. Couldn't make fists. Feet were tight. Stayed hydrated. since then for the past week I have been taking motion sickness meds the dizziness has not gone away. Went to the Emergency room on 1/28/21 as the symptoms still haven't gone away. They ruled me out for a stroke. I felt completely normal before the vaccine. I had CT scan done, MRI both came back normal. The diagnosis that was the outcome was vertigo.

Upper arm sore around injection site; Mild headache; Excessive tiredness; Bad taste in mouth. Sharp pain in collar bone around during the 15 min waiting period of after injection.

Intense thirst lasting 24 hours, abnormal bowel evacuation, mild loss of sensitivity to smells and tastes

I am going to describe all my symptoms so far in detail. Shortly after the shot in the medical observation area I experienced mild nausea that went away for the rest of the day. About an hour after the injection, I experienced nasal drainage in the back of my throat that lasted about 30 minutes. 3 hours after my shot, the arm pain at injection site began, followed by 6 hours later moderate to extreme fatigue that did not cause me to be sleepy or drowsy--simply fatigued. I had enhanced sense of taste and smell. On Wednesday, 1/27 I woke up seeming okay and tried to work at my computer from home. I experienced light-headed and dizziness, and a headache that feels like pressure, and sinus pressure at the bridge of my nose. I had to disengage from work. After lunch around 2 PM I had extreme fatigue and had to lie down in bed the rest of the afternoon and evening. I have moderate nausea that comes in goes in waves. This morning, Wednesday, 1/28 I woke up with nausea and ate breakfast with a heightened sense of smell and taste. I logged into work and the lightheadedness and dizziness began again (also sort of in waves, though the headache is more pervasive and less wave-like than the nausea), along with waves of moderate nausea and headache. The arm pain at the sight of injection has significantly abated from a punch to mild pain. The "sinus" or sinus pressure on the bridge of my nose seems only a fraction improved. The headache or pressure has moved from the back of my head to the right side of my head. I had no body aches, but this morning has mild to moderate body aches this morning in my legs and hip bones. 1/29 I woke up with 20%-30% reduced symptoms of nausea and headache, but the dizziness and sinus pressure on the bridge of my nose remain the same. I still have enhanced taste and smell (a sensory plus it's not a distorted or odd enhancement, simply the same flavors and tastes enhanced). The ache that began yesterday in my lower body, my legs still ache, though it feels more like numbness than an ache. I tried doing some stretches which felt good, but my legs still feel the same after stretching. Pain at the site of injection is reduced 90%. There are some strawberries sitting next to me, and I can smell them acutely. Yesterday, 1/30, I woke up with mild nausea and fatigue. This nausea dissipated in the morning, but I felt too fatigued to do Pilates. The waves of dizziness and waves of nausea returned mid-day and I had a low-grade fever of 99.4 (my temp. Tends to run slightly lower than 98.6, as I take it regularly). The pain/pressure in the bridge of my nose has reduced 30%, but still remains. The ache or numbness in my thighs remains the same. This morning, 1/31, my temp is normal at 98.6, but I have mild waves of nausea and moderate waves of dizziness. The pain/pressure on my nose remains the same as yesterday. I have some mild ear pressure. My thigh weakness remains the same. I am too fatigued to attempt Pilates. Acute sense of smell and taste remains the same. The headaches or pressure also seem improved since Saturday 1/30. Monday, 02/01 - ah back to work I woke up with moderate nausea and pretty intense body fatigue and muscle aches in my lower body. I had to work, and I just wanted to crawl back into bed. I worked anyway, also the fatigue tends to worsen mid-day. The dizziness is moderate in waves, and the headache is still mild, along with that mild sinus pressure on my nose. I was in bed after dinner but could have rested all day. 02/02 I awoke with a very mild nausea! The intense fatigue (which worsened several days past my vaccine) was mild. I was ready to attempt my regular Pilates routine, and I did it! My muscle aches are mild to moderate (also, why are my muscle aches mostly confined to my thighs and hips I do have vague pain at the injection site, but its vague, and I use my whole body in Pilates) dizziness waves are back as I sit here typing and get ready to login online to my job staring at the computer screen is jarring to the dizziness waves and reminds me of the mild headache. This is the best I've felt since 1/27 through mid-day I tend to worsen and dizziness that is moderate is disturbing. The heightened sense of taste and smell also seems to have waned a bit in the past two days, back to what I was per usual? I tend to have an acute sense of smell and taste. *I would like it noted in light of new evidence that many people that have had COVID are experiencing intense reactions to the first dose that it is quite likely that I had COVID back in March when my learning center (I work with students age 4-adult, some of which are learning disabled and have autism) emergency closed because a client called to say she was positive for COVID. I had taken her sons temperature the day before. Me, and my two co-workers on my management team were also feeling sick. I had a sore throat and chest pains for approx. a month, but at the time COVID testing was not widely available. Since then, My co-worker has tested positive twice for the antibodies, and her husband, who was also sick at the same time, has tested negative twice. I tested negative once for the antibodies, though given my job, my commute on the subway during rush hour my co-workers positivity, and my intense reaction to the first dose I most likely had COVID. My boyfriend's roommate recently also revealed that he is positive to the antibodies, and he was literally sneezing and coughing in the same room with us this past summer and spring. I think a 2nd dose of the same vaccine will cause fainting and vomiting, and the need for two weeks off of my work. This dizziness is alarming. I'm also thinking not having antibodies means nothing in terms of my body and immune system recognizing the vaccine and the virus, making me more ill than when and if I actually had COVID in March or last year.

13 hours after vaccine I woke with a fever around 103 with chills, body aches, joint pain, headache, ear pain and upset stomach. All of Saturday these symptoms went on and I had a tightness in my throat, not pain. I was very delirious and speaking jibberish when awake. Sunday the fever lessened and I felt more alert, but a large swelling started in my armpit in the left arm. Monday the fever was gone but I still had major joint pain, off and on headache and overall sick feeling. Today I woke and have a very upset stomach and achy feeling all over. The lump in my arm pit has gotten smaller but is still painful and visible.

She took the first Pzfier vaccine December 16 and 6 days later, she had complete hearing loss in left ear. She first noticed the loss of hearing occurred after a run. The pt had a piercing headache and the next morning she could not hear out of left ear. She recalls having a slight headache and tingling on the left side of her face, just after the vaccine. MRI of the brain normal. Prednisone taper, starting at 60 mg and received intratympanic steroid injections. The steroid did not help her regain her hearing. She was then seen by doctor and underwent a dozen hyperbaric O2 therapy. Pt is beginning to get her hearing back in left ear.

Left eye ball/socket soreness when moving side to side, up and down; Sinus pressure left eye; This is a spontaneous report from a contactable other hcp. A 42-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (lot number: El3248), intramuscular, in the left arm, on 08Jan2021 16:45 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient received the first dose of BNT162B2 on an unspecified date for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The patient experienced "left eye ball/socket soreness when moving side to side, up and down" and sinus pressure left eye on 10Jan2021 10:00. the outcome of events was recovering. Therapeutic measure taken as a result events included Sufdafed. No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.

Vaccine 1: flu like symptoms, severe headache, rash, severe body aches, fatigue for about 4 days. Vaccine 2: Nausea, diarrhea, fatigue, severe body and muscle and joint aches, headache, temporary loss of taste and smell again. Lasted about 30 hours. Diarrhea persisted for 6 days.

Report chills, HA, eye pain and muscle pain (leg). Treatment: none, Outcomes: continues to work, does not interfere with ADLs.

Patient complained of headache, nausea, dizziness, and burning sensation on upper lips 10-15 minutes post-injection.

Loss of taste; This is a spontaneous report from a contactable health professional, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular in the right arm on 22Jan2021 at 15:45 (at the age of 42-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported; however, it was reported that the patient received other unspecified medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. On 23Jan2021 at 09:00, the patient experienced loss of taste. The patient was not treated for the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of loss of taste was resolving. Information on the lot/batch number has been requested.

Intermittent loss of taste and smell. I was diagnosed with covid Nov 10, 2020 and lost my sense of smell and taste through Nov 24, 2020, since then I have had full taste and smell. About 6 hours after my 2nd shot things began to taste like cigarette ash, but my smell was fine. Then that evening things returned to normal. The next morning through about 1pm I was fine, things began a bit off around 1pm. By 4pm my taste and smell was gone on Sunday. Monday I have some smell and taste but it comes and goes. For instance I could taste the arugula in my salad but not the tomato. I could not taste a tangelo, but could taste a blood orange, eaten one right after the other. I now have most smell back as of 2pm Monday, but taste is intermitten.

12-30-2020 Erythema, soreness and itching on right arm below the injection site. 12-31-2020 Nausea. Itching and erythema. Ears began to swell and became hot and red. Face and neck uncomfortable. Took Benadryl when went to bed at midnight. 1-1-2021 In evening began severe itching and erythema form head to breasts including arms which lasted three hours. Right eat internal soreness. 1-2-2020 Fifteen minutes after eating began sudden stomach crapms and then larger amounts of diarrhea and vomiting. Later had another episode of vomiting and diarrhea. Felt weak with labored breathing, chills, Fever 100.2, another bout of diarrhea and vomiting. Productive cought that started in the evening with clear mucous.

Client reports that she was feeling weird and was not a panic attack as she has had them before. She states that she was lightheaded, dizzy and that her tongue started to well and she couldn't swallow. Client reports that she received Benadryl, and anti nausea medication. Client was transported to the local hospital. Client states that she could still breath through her nose and that she was only in the ER for approximately 2.5 hours.

15 minutes after received COVID 19 vaccine, developed shortness of breath, dry mouth and throat dysphagia, high blood pressure and anxiety.

I had headaches, had a single event of lip swelling, upper lip. I had a cardiac issue, having PVC, pre-ventricular contractions. I had work up done. I had to get an IV of magnesium. I still have those symptoms intermittently and I am being followed up with my cardiologist.

-ADR: Allergic reaction (SOB and throat tingling/swelling -Inpatient - 0.9% NaCl Bolus, famotidine (PEPCID) injection 20 mg ,diphenhydrAMINE (BENADRYL) injection 25 mg, methylPREDNISolone sod succ (SOLU-Medrol) injection 125 mg, diphenhydrAMINE (BENADRYL) injection ADS Med, famotidine (PEPCID) injection ADS Med -Treatment: discharged with Benadryl and Medrol Dose pack

Employee states she developed a migraine the evening after receiving her 2nd COVID vaccine. She took medication which help dull the headache. She woke up the morning of 2/11/21 with hives on her face. She states her face was red and her eyelids swollen. The left eye lid more than the right. Employee took benedryl which helped, but her left eyelid remains red and swollen. Advised employee to contact her PCP.

woke with swollen tongue, throat, and all mucosal linings; woke with swollen tongue, throat, and all mucosal linings; woke with swollen tongue, throat, and all mucosal linings; Mallampati score 4, not my baseline; Moderate fatigue rest of the day; Sore arm was experienced within 5 hours of administration; This is a spontaneous report from a contactable Nurse reporting for herself. A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration at Left arm on 29Dec2020 17:15 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history included hypertension (HTN), ablation corrected Wolff-Parkinson-White syndrome, pre-eclampsia. The patient was not pregnant. Concomitant medication included hydrochlorothiazide, triamterene (MAXZIDE), ibuprofen, naproxen sodium (ALEVE) and Women's multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took trolamine polypeptide oleate-condensate (CERUMENEX) and experienced allergy. The patient's sore arm was experienced within 5 hours of administration on 29Dec2020. Next morning 15 hours post, woke with swollen tongue, throat, and all mucosal linings. Mallampati score 4, not her baseline. Moderate fatigue rest of the day. Finally took Benadryl at 23-hours post vaccine, had to repeat Benadryl every 8 hours for 2 more days and monitor symptoms, events onset date was 30Dec2020 08:30. Adverse events result in: Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovered on an unknown date.; Sender's Comments: Considering the temporal association, a causal association between administration of BNT162B2 and the onset of Swollen tongue, Throat edema, Oral mucosa swollen, and Physical examination abnormal cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

I felt fine that day and waking up the next. Then as I moved around, I started to feel uneasy. I vomited forcefully several times. My neck and upper back became stiff and painful. Then came chills, shaking, and more nausea. My throat felt like there was a lump in it that was closing me off. I felt very weak and easily fatigued. I started to have visual issues, confusion, and was unable to focus. Neck pain continued to be severe. The next morning I woke feeling good, but within 2 hour again I went downhill. Symptoms are only about half as bad as the day before. Very very tired.

Information provided by patient as follows. I do not have access to urgent care notes to provide that information. ALLERGIC REACTION TO VACCINE. SWELLING IN INNER AND OUTTER BOTTOM LIP. THROAT AND EARS ITCHY AND THROAT FELT TIGHT. DIFFUCULTY SWALLWING. WENT TO URGENT CARE AND RECEIVED STERIOD SHOT.

smelled something like cigarette smoke; stomach cramps; left arm was in pain, more pain that it had been/pain was in her scapula, her left arm, all of her joints; pain was in her scapula, her left arm, all of her joints; could feel her blood surging through her body; she couldn't get comfortable; Crying; Allergic reaction; body aches; dizziness; hallucinations; up all night; exhausted/ fatigue; This is a spontaneous report from a contactable other healthcare professional (patient). A 42-year-old female patient received the first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Lot number: EL9261), via an unspecified route of administration at the right arm on 22Jan2021 14:58 at a single dose for COVID-19 vaccination and ketorolac tromethamine (TORADOL), via an unspecified route of administration on 22Jan2021 16:30 at an unknown dose, single for pain. The patient medical history includes low iron anemia from Oct2020 and allergy to eggs, pecans, walnuts and latex. Also on 15Jan2021, she fell down the stairs and thought she broke her arm and was in severe pain. The has been taking iron supplements as concomitant medications. The patient reported having hallucinations, body aches, fatigue and dizziness on Jan2021. On 22Jan2021 09:00PM, she started smelling smoke, like cigarette smoke, like her home was filling with cigarette smoke, and no one in her house even smokes. On 22Jan2021, she also had severe stomach cramps like she was going to have diarrhea, but she never did. She says she was bowed over with the worst cramps like menstrual cramps, and her left arm was in pain, more pain that it had been. She says she could feel blood surging in her legs, it was almost surreal, she could feel the blood going through her body, which she never had felt something like that before. She says that the pain was in her scapula, her left arm, all of her joints. She says she could not get comfortable, and she was crying she was in that much pain. She says she does not typically cry and has a pretty good pain tolerance. She says she was getting freaked about that, and the next morning she was exhausted (Jan2021), she would assume since she was up all night in pain (Jan2021). The following day she laid around and felt extremely fatigued and dizzy, then by Sunday she was feeling better. For pain treatment she took Ibuprofen though her doctor also prescribed her another pain pill for her arm, she was scared to take it, so she took Ibuprofen 600mg which was also prescribed to her. The patient said that she did not think it was an allergic reaction but her doctor thought it might have been. The action taken in response to the events for ketorolac tromethamine was unknown. The outcome of the events was unknown.

could not lift arm/move body; her tongue started to be tingly; fuzzy feeling; tongue swollen a bit; hives; hard to swallow; weird taste in mouth; a high grade fever over 103, went down on 03Feb2021 to 102, 101, 99, then 98.6; chills uncontrollably; heart racing a bit; joint-muscle pain; headache; dizziness; swollen lymphnodes; red rash on chest/arms/stomach with some hives; This is a spontaneous report from a contactable consumer reporting for herself. This 42-year-old non-pregnant female patient received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EN9581) on 02Feb2021 at 10:30, in left arm, for COVID-19 immunisation. The first BNT162B2 vaccine dose was administered on 12Jan2021 at 13:30, lot number EL3246, in left arm, for COVID-19 immunisation. Medical history included heart murmur, acute sinusitis, allergies to acetaminophen/oxycodone (PERCOCET), cephalexin (KEFLEX), codeine, trees, pollen, grass, mold, cats, some dogs. The patient had no COVID prior to vaccination and COVID was not tested after vaccination. Concomitant medications were not reported. The patient received the second vaccine dose on 02Feb2021 at the hospital and was monitored for 30 minutes. Within that time her tongue started to be tingly, she experienced fuzzy feeling, tongue swollen a bit with hives, hard to swallow, weird taste in mouth. The nurse on staff walked her to the ED, she was admitted and treated for allergic reaction to the vaccine and received prednisone for 5 days and diphenhydramine (BENADRYL). Epipen if needed. Later that night, on 02Feb2021, the patient had a high grade fever over 103, chills uncontrollably, heart racing a bit, could not lift arm/move body, joint-muscle pain, headache, dizziness, swollen lymphnodes, hard to swallow, every side effect on sheet just really bad. Her fever eventually went down on 03Feb2021 to 102, 101, 99, then 98.6. She still had all other symptoms not as severe, later that night she had a bit of a red rash on chest/arms/stomach with some hives, swallowing was still a bit hard. She continued to take BENADRYL and steroid. 06Feb2021 was her last day of steroid. As of 06Feb2021 she was feeling a bit better with no fever, swallowing a bit hard but other symptoms were less. The events resulted in Emergency room/department or urgent care. Fever resolved on an unspecified date in Feb2021. The other events were resolving.

About 3 hours after the afternoon shot, I noticed I began to feel bad. Not in any specific way, just bad. That evening, I noticed chills, pressure at the top of my head, sensitivity to sounds, and aching body. That night, I had trouble sleeping due to all of this. The next day, an additional thing I noticed was how much my lymph nodes hurt, especially in the throat and armpits. The left armpit in particular was more swollen and painful than at any other time in my life. I could not put my arm down without pain. The day after that, the feelings subsided. This 3rd day after the shot, my left armpit lymph node is a little sore, but I am able to do my daily activities. I took children's chewable aspirin tablets the first evening, day and 2nd evening.

Patient reports that she received dose one of the Pfizer COVID-19 mRNA vaccine last Friday, February 5, 2021 at 2:03 PM. She received this here at facility campus vaccine clinic. She felt a strange tingling sensation immediately upon receiving the injection that extended from the injection site across her upper back but otherwise tolerated the injection well. Because of her history of food allergy she was advised to remain at the vaccination clinic for 30 minutes. During that 30-minute wait period she felt generally well however began to develop pruritus at her back in the legs. She did not mention this to the staff at the vaccine clinic and did not look at her skin. The pruritus was not too bothersome and she left the vaccine area after 30 minutes and walked down to our clinic to return to work. Her pruritus intensified very quickly upon returning to her desk and within a few minutes of after her return she went into the bathroom to look at her back and had patches of red, raised, urticarial lesions across her back. She began to feel itchy all over her body. She remained at work and did not take any medication or seek any medical help. She did not look at her legs. The pruritus intensified and when she looked at her skin of her legs approximately 1 or 2 hours later she had developed urticaria essentially head to toe. She had large confluent patches of urticaria at bilateral thighs, urticaria at her face, trunk, arms, legs.   At this point she felt otherwise well. She went home and took 10 mg of Claritin and applied a topical Benadryl cream to her skin. This was not helpful. She had severe pruritus of her eyes and eyelids. She took 50 mg of oral Benadryl which also was not particularly helpful. Sometime in the middle of the night that night she developed chills, felt feverish, and developed intense muscle and joint aches. She took an unknown dose of ibuprofen with minimal improvement in muscle and joint pain. She did have improvement in fever. Following day was Saturday, she spent the whole day in bed in extreme pain. She describes the pain at her wrists as feeling as though "somebody was breaking my bones" with any movement of her wrists. She had pain even laying flat in her bed and had severe pain at all of her joints with movement. She tried taking a flexeril with no improvement. She recalls a T-max of 102 sometime on Saturday or Sunday. At that time she had been taking ibuprofen around-the-clock. She also took 10 mg of Claritin approximately every 4 hours. Each night she also took 50 mg of Benadryl. She continued to experience urticarial skin rash and intense pruritus of the skin. The urticaria waxed and waned during this time. She also developed a fever blister at her lower lip. She spent most of Sunday in bed also. She was feeling a bit better by Monday however still had intense pruritus. Skin rash was much improved at most of her body however she still had mild urticaria at her face. She did not have a fever on Monday but was continuing to take ibuprofen around-the-clock. She discontinued ibuprofen yesterday and has not had fevers or chills since Sunday. At this point her urticaria has essentially resolved. She continues taking claritin 10mg BID to 3 times a day and also 50mg bendaryl at bedtime.   She did not experience any bruising related to this rash however did have excoriation from scratching particularly at her face.   Throughout the course of these days she did not have any episodes of angioedema of the lips, tongue. She denies difficulty breathing, cough, wheezing, shortness of breath, throat tightening, nausea, vomiting, diarrhea, dizziness, lightheadedness, syncope.   She has a history of oral allergy syndrome with peanut. Promethazine has caused diplopia, weakness. Simvastatin caused muscle weakness. She has never had any issues with vaccines. She has been getting a flu shot yearly with no difficulty. Her most recent vaccine was October 8, 2020, quadrivalent influenza vaccine.   No known history of allergy to polyethylene glycol.   No history of chronic urticaria. She takes NSAIDs frequently without any difficulty. She has not taken any NSAIDs prior to receiving this injection or developing this urticaria. She had however taken 10 mg of Claritin prior to receiving this injection.   She has no history of anaphylaxis. She has undergone surgery under general anesthesia on more than one occasion without issue. No history of reaction to stinging insect venom. She receives immunotherapy for inhaled environmental allergens here in our office and has done well with this.   She denies any recent medication changes or new over-the-counter medications.   She has not previously been diagnosed with COVID-19.

Client reported "tingling in back of tongue and throat." Sensation lasted 15-20 minutes. Resolved without medication intervention. Client reported, "Sensation is gone. I feel okay now."

Per patient report, 7 mins after vaccine she felt a head rush and felt faint. had a rash on chest, increased HR and BP. Given Benadryl, was monitored and released. She felt normal from 2/15 to 2/18. Then on 2/19 she felt dizzy, tongue felt fuzzy, heart rate erratic. Came to the ED. Had normal labs. Vitals normalized. Went home. Thereafter from 2/19 to 2/23, felt dizzy, had erratic heart rate, was light headed and was having a hard time focusing. Came back to the ED on 2/23 and had a HR of 135 and BP of 177/108. Got IV fluids and vistaril. Her HR improved to 119 and her BP improved to 161/98.

anaphylactic reaction; Flush face with itching; Flush face with itching; throat became itchy; tongue tingled; sore/scratchy throat; metal taste in mouth; shakiness (like internal vibration); This is a spontaneous report from a contactable other hcp. A 42-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration arm left single dose on 03Feb2021 08:00 for covid-19 immunisation. Medical history included depression, anxiety, drug hypersensitivity to codeine, sulfa meds, influenza vaccine, food allergy to quinoa. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), colecalciferol (D3), docosahexaenoic acid, eicosapentaenoic acid, tocopherol (OMEGA 3), probiotics. The patient experienced anaphylactic reaction on 03Feb2021 08:30, flush face with itching on 03Feb2021 08:30, throat became itchy on 03Feb2021 08:30, tongue tingled on 03Feb2021 08:30, sore/scratchy throat on 03Feb2021 08:30, metal taste in mouth on 03Feb2021 08:30, shakiness (like internal vibration) on 03Feb2021 08:30. Patient went to Emergency Room and was treated with Benadryl, Pepcid C, Decadron, Epi. The outcome of the events was not recovered. Information on the lot/batch number has been requested; Sender's Comments: Based on the available information, a possible contribution of the drug to the event anaphylactic reaction cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Painful injection site after 10 minutes of injection that lasted for about 2 hours, then it was only sore. After about 2 hours, I started to had a bad headache and pain and numbness under my left jaw.

Itching on neck, arms, face, ears, chest-burning. then tongue, throat itching client treated self with 25ml of Atarax saw improvement after 10 minutes; left on own accord.

Woke up 2 days later with red eyes and hives near the injection site. Throughout the day, the hives traveled down the left side of my body. I sought treatment at Urgent Care. They prescribed 4 mg pack of 5 day steroid. On Saturday morning, the hives returned worse and covered my entire body except my face. The injection arm was swollen and red. I also begin to have shortness of breath. I went to the ER and they gave me an IV of benedryl and prednisone. I was released with another 4 day course but with 20 mg of steroid .

sore left arm shot area chemosis- thought I had something in my eye, a cat hair since I had been petting put cat. skin around right eye slightly swollen. Realized the liquid was under clear part of eye. Looked like some bubbled coming from top of eye, so weird. Could feel the liquid moving in eye when moving head. Touched the eye, liquid spread around iris and pupil not going over it. Was so weird. No pain. Felt that it had to be a reaction to the shot. My body seems to be pretty sensitive. I have had cold sore a few times back to back due to stress. My youngest has Cystic Fibrosis that is what allowed us to get the vaccine, in home caregiver of medically fragile child. Went to urgent care, just needed a professional to say it would go away in a few days and note the reaction. The PA said it was not a reaction to the vaccine, that it is not listed as a reaction in the data. Blah blah blah. I disagreed and left it at that. Had a benedylt last night and put a pataday drop in eye as recommended by PA

Lip tingling/fizzing; This is a spontaneous report from a contactable nurse (patient). A 42-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL 3246), via an unspecified route of administration (at the age of 42-years-old) on 21Jan2021 10:00 at a single dose in right arm for COVID-19 immunization. Medical history included none. No allergies to medications, food, or other products. Concomitant medication included rosuvastatin calcium (CRESTOR), spironolactone, tacrolimus, and macrogol 3350 (MIRALAX). The patient experienced lip tingling/fizzing on 28Jan2021 19:00 with outcome of recovering. No treatment received for the adverse event. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The event was considered as non-serious.

3/2/21: Shot about 7:30 am I. Arm. 2ish feeling tired and sluggish but not too bad. 4pm low grade fever and tired. 6:30 high fever 103 fever chills, shaking from chills. Lasted about 4 hours. No meds taken to offset. About 11 hot and tired. Hot with fever about 99-100.5. Up and down all night from being sore and not able to get comfortable. As well as feeling hot. Thirsty. Mental fog. 3/3/21: very tired. Wore out by simple tasks. Slept most of day. Achy body. A few slight fever times but not bad. Slept 18 of 24 hours. Times awake we?re just sitting. Mental fog. Even hearing someone else talk would wear me out. Went to bed at 6:30 pm. Was very tired but trouble falling asleep because could not get comfortable so took an Advil pm. Slept until 5:50 only getting up once to use bathroom. Did wake up in puddle of sweat when we to bathroom. 3/4/21: still tired feeling but feel much better. Mental fog way better. No fever. Feel alert and awake. Not feelingwore out by simple tasks. Location of injection: and arm response. Vaccine 1 given was about 2-3 inches down from shoulder joint. Very sore arm for 5 days. 3 days could raise arm or move without it hurting. Vaccine 2 given was no more than 1 inch down from shoulder joint. I was asked to pull T-shirt sleeve up further before getting it. It was much higher in arm than vaccine #1. 2 hours after vaccine arm was very sore. By 4 hours after arm hurt and not able to move it without pain. Did not use arm for even small normal tasks like taking a drink. By time fever broke around 11 pm, Arm felt much better. Sore but no pain to move it or use it for normal activities.

42 yr old female patient complaining of sensation of (L) inner ear swelling as with food and mold allergens. Area below (L) eye slightly itchy. No redness or swelling noted of ear or eye.

About two days after my vaccine, the area under my eyes significantly puffed up. About 6 months ago I had cosmetic fillers put under my eyes and the vaccine caused a reaction

10 minutes after the injection mouth tasted like metal, heart racing, body shakes, cold limbs, feeling of being hot and cold, sheer panic. Symptoms were very strong for the first few hours after injection. Jittery, shaky, uneasy feeling persisted for about 48 hours.

Fever; chills; soreness at injection spot; body and joint aches; body and joint aches; headache; nausea; eye ache and watery; eye ache and watery; This is a spontaneous report received from a non-contactable consumer (patient). A 42-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 9267, expiry date: unknown), via an unspecified route of administration in the left arm, on 13Feb2021 09:30, at single dose, for COVID-19 immunization, at the hospital. There were no medical history and concomitant medications. The patient has no allergies to medications, food, or other products and was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 9261, expiry date: unknown) received at 42 years of age, via an unspecified route of administration in the left arm, on 23Jan2021 09:30, at single dose, for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the BNT162B2 vaccine. On 13Feb2021 at 18:00, the patient experienced fever, chills, soreness at injection spot, body and joint aches, headache, nausea, and eye ache and watery. No treatment was given for the events. The patient recovered on an unspecified date in Feb2021. The reporter assessed the events as non-serious. No follow-up attempts are possible. No further information is expected.

Puffy, swollen eyes. Hives all over body. Every single part of my body. Been going on for 36 straight hours now. No relief. Treating with calamine lotion and round the clock benedryl. No breathing issues.

17 mins after the vaccine I had a weird feeling in both my legs and both my lips went numb (cheekbones down to my chin) and numbness in my fingertips.

Allergic reaction 12 hours after vaccination. Diahrea, hives, flushing, rapid heart rate, swollen lips

Neuropathy, Anxiety, Nausea, Vivid dreams, Head squeezing, Shortness of breath, Fatigue, Light Sensitivity. Going on a week now This was my first vaccine.

Shortly after receiving vaccine, experienced scratchy throat, difficulty swallowing and tingling of lips. EpiPen administered x 1 without improvement of symptoms. 911 called transferred to hospital by ambulance.

The logistician from station 3 alerted the observation area that a patient was not feeling well. The patient was sitting on the chair. She looked pale. She complained of feeling dizzy and lightheaded (went away 2 mins after getting the shot) and blurry vision (went away 5 seconds after getting the shot) Blood pressure: 118/76; Pulse 68. O2 sat unable to read d/t nail polish. Good capillary refill. She felt better after 20 minutes. She rested laying down with her feet elevated for 20 minutes. She sat down for 15 minutes and stood up for 5 minutes with no dizziness/lightheadedness. Patient texted that she arrived home safely and felt fine.

Extreme neck pain, difficulty moving neck, gout like symptoms in feet, extreme fatigue, shakiness, flu like symptoms, swollen red knuckles on left hand that were stiff and painful, fainted, dizziness, vision disturbances

3-13-21 2:30PM RASH TO FACE & NECK. NO SOB/DYSPNEA, NO PAIN. 2:32PM BENADRYL 50MG PO. 2:36PM STATES SHE IS 'OK AND READY TO GO HOME'. NO ACUTE OR OBVIOUS DISTRESS. A/O X3, PINK, W/D, RESP REG WITH EASE. NO CHANGE IN RASH AT THIS TIME. AMBULATORY, GAIT BRISK AND STEADY. 3-15-21 9:30AM TC: STATES 'RASH IS GONE, EARS STILL FEEL RAW AND STILL TAKING ALLEGRA'. WILL CHECK WITH PCP R/T DOSE #2.

Swollen bottom lip Major swelling more than my normal in my legs and hard to move knees Around injection site big red area showed up about 2 weeks after 1st dose

Severe pain in my left jaw; it (jaw) locked up/face froze; difficulty swallowing; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6202), via an unspecified route of administration in the left arm on 25Feb2021 14:00 at a single dose for COVID-19 immunisation. The patient's medical history included diagnosed with COVID-19. The patient have no known allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine but had other unspecified medications within 2 weeks of vaccination. On 25Feb2021 20:00, the patient experienced severe pain in her left jaw then it (jaw) locked up. Her face froze. She had difficulty swallowing. The patient had not been tested for COVID-19 since the vaccination. Therapeutic measures were taken as a result of the events and included treatment with muscle relaxer, heat and ice, and rest. Outcome of the events was not recovered.

10 minutes after receiving second Covid vaccine, tongue and mouth felt tingly and scratchy. denies difficulty breathing or throat closing. Had similar symptoms with the first vaccine., Discussed with her PCP who gave her a note to have her second Covid vaccine but to take Benadryl 50 mg po one hour prior to shot which she did. Denies any drowsiness, stating she takes benadryl on a regular basis frequently. Ambulated with staff to med: Appears somewhat anxious, oropharynx patent, pink, moist mucus membranes, BP 128/62, T 98.6, Chest: CTA. RRR, HR 64. AAOx3, clear in conversation, ambulatory without difficulty. Declined transport to the ED or urgent care for continued care/follow up, although symptoms are not worsening but stable, and her anxiety decreased, during her 40 minute stay after the vaccine. Again, denied drowsiness and symptoms abating. She then left the unit for home at 2:40pm

15: 47pmPt in post Covid vaccine waiting area, 1st dose administered. Pt c/o feeling hot and "my ears are swelling like I'm on a plane". Pt reports having history of "severe allergies" Vital Signs: BP 162/75, HR 122, SPO2 99%. Reassessment 15:52 Vital Signs\ BP 138/84, HR 100, SPO2 99% Nurse alert alarmed, Pt transported via wheelchair

WITH IN THE FIRST 15 MINUTES I EXPERIENCED DIZZINESS. WITHIN THE FIRST HOUR MY EYE BROWS SWELLED AND I HAD A RIGHT SIDED FRONTAL HEADACHE. I TREATED WITH ICE PACK, TYLENOL, AND CLAIRITIN. 2 HOURS LATER I FELT LIKE I WAS AT HIGH ALTITUDE WHICH LASTED FOR 36-48 HOURS. tHE SWELLING BROKE DURING THE NIGHT WITH MASSIVE EYE TEARING AND POST NASAL DRIP. I CRAVED BLACK LIC0RICE LIKE MAD.

Patient had 2nd Pfizer COVID-19 vaccine on 1/11/2021. On 1/12/2021 developed loss of taste/smell, rhinorrhea. Positive COVID test.

~5 minutes after injection, developed flushing and altered taste. Flushing resolved within 5-10 min. Taste was very proncounced, slightly metallic and very salty and lasted remainder of the day with associated nausea. Taste alterations resolved that day. Slight arm soreness and moderate fatigue for next 2 days, then resolved. On day 6, I developed fevers, the odd taste changes that I had post-vaccine returned, and fatigue. Felt "off," similar to when I had presumed COVID in March 2020. Fevers (100.5 on Advil), fatigue, felt "off." No cough/shortness of breath. Symptoms peaked on day 8, then I woke up feeling great on day 9. Minimal reaction to dose #2.

Sore arm, joint pain, nausea, fever. But later that afternoon EXTREME fatigue set in. I have slept for the majority of the last 3 days. I wake up foggy and disoriented. Takes a while to focus and become alert. I use the restroom and maybe I'm able to be active for 15- 20 minutes then I'm back asleep, or too tired to keep my eyes open. Today is the first day I have been able to stay awake more than an hour. I had energy for about an hour and then felt like I was unplugged I'm just too tired to function. All I can do is go back to bed.

I have a big brain head aches from the outside in; Feel like I?m walking slanted when I?m walking straight, can?t think in depth (it?s challenging to write graduate level papers); have to absolutely sleep 8-12 hours a night otherwise, I cannot function well with multi tasking as I did before the vaccine; Thirsty a lot more than usual, coughing sore throat (maybe this is normal w/the vaccine, I?m not sure). Today at 9:00pm, I realized that I lost my sense of taste. I ate a pizza and could not taste it. I am able to taste really sweet juice with my taste buds near the back of my tongue. This was something different today which is why I wanted to report. It does not feel like it is life threatening. Just uncomfortable to deal with. I?m so glad that I received the vaccine. If this is all that happens to me then , I am thankful for being alive and just having to deal with these discomforts while the vaccine is working through my system. Just note the symptoms maybe this is something in common with other people too.

Started with a dry throat after 15 minutes -3:45. Thought I just needed water. Drank water in car and as we continued to drive my face started tingling and feeling numb. I called the pharmacy at 3:50 and said I should take Benadryl or go to ER if symptoms worsen. I took liquid Benadryl 10ml at 3:55. The feeling continued for the next three hours. The feeling in my throat went away but the tingling feeling continued. On 3/20/2021 I went to urgent care at 9:40am due to continued tingling and numbness in the right side of my face and heaviness in my right arm . I was prescribed prednisone.

lymph nodes hurt extremely, esp in throat and armpits; Left armpit node was so swollen and painful, it was difficult to put my arm down; feeling bad in a non-descript way; sensitive to sounds; feeling pressure in my head at the top third of it; chills; body aches; Couldn't sleep due to discomfort; discomfort; This is a spontaneous report from a contactable healthcare professional (patient). This 42-year-old female patient received dose 2 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE; lot number EL9264) via an unspecified route of administration on 16Feb2021 at 13:15 (at the age of 42-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included endometriosis, depression, anxiety, thoracic scoliosis, and a herniated disc at L4-L5. The patient was not pregnant at the time of vaccination. The patient had not been diagnosed with COVID-19 prior to the vaccine. The patient had not received any other vaccines within 4 weeks prior to the vaccine. Concomitant medications included bupropion, citalopram, and tramadol from unknown dates for unknown indications. The patient previously received dose 1 of BNT162B2 (lot number EL9261) on 28Jan2021 as a single dose in the left arm for COVID-19 immunization. The patient did not have any allergies to medications, food, or other products. On 16Feb2021 at 17:00, a few hours after the vaccine the patient noticed feeling bad in a non-descript way. Soon after in the evening she was sensitive to sounds, felt pressure at the top third of her head, chills, and body aches. She could not sleep that evening due to discomfort. On 17Feb2021 lymph nodes hurt extremely especially In the throat and arm pits. The patient's left armpit node was so swollen and painful it was difficult to put her arm down. The second day the symptoms were the same but lessened. The third day only the left armpit node hurt a little. The events were reported as non-serious. The patient was not hospitalized for the events. The patient received treatment with children's chewable aspirin in the evening of 16Feb2021 and the day and evening of 17Feb2021. The outcomes of feeling bad in a non-descript way, sensitive to sounds, pressure at the top third of the head, chills, body aches, couldn't sleep due to discomfort, lymph nodes hurt, and left armpit node swollen and painful were recovering. It was also reported that since the vaccine, the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.

Patient received dose at a clinic provided by store pharmacy at 9:30 AM on 2-25-2021. Patient stated she started to have anaphylactic reaction to the Pfizer -Biotech COVID vaccine around 7:00 PM that same day. Her eyes swelled up and her throat started to feel like it was closes so she went to the ED at Hospital. At the hospital, she received an Epipen and a shot of benadryl. The reaction was taken care of and she was able to return home later that night with no lingering effect of the reaction.

Terrible taste in my mouth with certain foods. Toothpaste, meat, veggie chips, coffee and other things all taste like an ashtray smells.

Ringing in the ears. I have seen Primary care doctor, ENT and acupuncturist. Ringing still persists. All doctors agree it will go away and is inflammatory response. It has NOT resolved as of today.

High Fever started at 9am on 3/21/21, got as high as 105 degrees by 3 pm. Chills, severe joint pain, dizziness and blurred vision.

Tongue, lips swelling, hands and wrists (fingers) numb and tingling. Vaccine administered 1:38pm Benadryl 50mg PO administered 1:50pm Epi pen given at 2:10pm

Light headed and dizzy beginning approximately 10 minutes post vaccination. Swelling of tongue and itching in throat beginning approximately 20 minutes post vaccination. At this point patient notified observation nurse. Assessed by EMTs and nurse practitioner on site. Received injection of 25 mg of Benadryl. Began having relief of symptoms within 3 minutes. No Transported to hospital for observation. Received oxygen during transport. ER gave famotidine and loratadine via pills at 3:44 pm. Observation for approximately 70 minutes. At this point it had been approximately 4 hours since injection. BP and oxygen levels good. No itching. Released and returned home. Patient was cold and tired, which is typical for them when receiving a Benadryl injection. Slept for approximately 14 hours. Currently tired and achy, which is again typical for them after receiving a Benadryl injection.

Pt vaccinated. On 3/12 exposed . Symptoms of cough, loss of taste/smell, HA, runny nose. Tested + for and inconclusive for quest.

Ear ache in left ear for several hours, tired, almost feverish feeling from late afternoon to evening the day of the vaccine and the late afternoon/evening the next day

I am 5 days out from the 2nd dose. I had to make an urgent care visit because of shortness of breath, blurred vision, light headedness, brain fog, nausea, fatigue, feeling of fainting and tightness in throat. These symptoms have been present and overwhelming for over 3 days presented themselves after day 2 of vaccine. The original symptoms of headache, body aches and chills subsided by day 3.

Numbness of the face as if I was coming out of dentist office. Still able to move my face but can not feel my skin. Ears felt as if I was underwater or going in plane (trying to pressurize)

In recovery pt stated "felt like numb head to feet I had cough and sore throat past couple days" (spoke broken English Asian decent) brought to recovery area in wheelchair to lie down supine Assess: - LOC, -SOB, - N/V, slight pale - Rash. - facial swelling, - tongue swelling. stated she was anxious to get vaccine Left Deltoid site benign, VS 130/72, HR 95 reg strong, resp 12 reg non labored. Medical called to evaluate. Encouraged hydration, Provided reassurance monitored 1 hr (per pt request) No further symptoms developed. Advised if anything occurs later in day call 911 if life threatening or go to urgent care. sign to V-safe . Ok'd to exit 9:45 am

Extreme tinnitus beginning the day following vaccine and lasting about 48 hours. Within two days, tinnitus reduced but has remained persistent for now well over a month. For last 3 weeks, experiencing intermittent extreme tinnitus in left ear followed by muffled hearing/hearing loss. Overall tinnitus volume now seems to be increasing/worsening.

After receiving dose, she began to feel warm, lightheaded, and nauseous. After ~15 min, she developed swelling in her tongue and took bendardyl (50 mg). Epinephrine was at bedside but not given. Reaction subsided. Vital signs were unremarkable. Physical exam was normal except for tongue swelling.

Encounter Date: 3/23/2021 Hide copied text Hover for details 245PM Pifzer first dose Vaccination given. 320 Complaining of not feeling well. States she stayed beyond her 15 minutes as did not feel well. BP 119/80 P86 R 18 Pulse ox 100%. When asked how she was feeling she stated she feels something in her throat. Complains of itching to her back. When examined, found many reddened areas with scratch marks over mid back near bra line. Consulted Dr. regarding giving Benadryl 25 mg po. She advised to administer. 325 Benadryl 25 mg given po. Denies difficulty swallowing but states not getting air as well. Lung sounds audible but diminished at bases. Unable to auscultate heart sounds per NP due to acoustics. 335 BP 125/85 P 132 R 22. Pulse ox 99%. States more difficulty getting air. Epinephrine 0.3 mg IM given complains of lip feeling tight. 337 Squad arrived and given report. BP 124/67 P138 R 22. Pulse ox 98%. Shivering from Epinephrine administration. Patient taken to Emergency Department, unable to see records from that facility.

About ten minutes after the vaccine I had a strange feeling that something wasn?t right. Vaccine arm started going numb with tingling. That hand then became completely numb. Then my throat went numb and face was tingling and couldn?t swallow properly. Found nurse at the vaccination site and reported not feeling well. She immediately noticed I was bright red and breaking out in hives. Nurse gave me an antihistamine shot and an oral antihistamine for an allergic reaction. I?ve never had an allergic reaction before or ever experienced any of these symptoms before. After a few minutes the symptoms started going away. I was advised to not drive myself home. About an hour later some milder symptoms came back, such as slight tingling of face and lips. Went away again gradually. Fell asleep (not sure how long) and woke up with swollen and numb lips so I took some more antihistamine. No more allergy symptoms after that.

Blurred vision, sensitivity to light, migraine headache 10 minutes after injection, heart palpitations within 4 hours of injection. Headache and heart palpitations still present now.

extreme pain in left side of neck with difficulty moving; fainted; dizziness; Extreme pain in left side of neck with difficulty moving; gout-like reaction in feet; arm pain; fatigue; weakness; body aches; left hand knuckles swelled turned red stiff and painful; left hand knuckles swelled turned red stiff and painful; left hand knuckles swelled turned red stiff and painful; headache; vision disturbances; shakiness; This is a spontaneous report from a contactable other health care professional (patient). A 42-year-old female patient (non-pregnant) received first dose BNT162B2 (Solution for injection, COVID 19, Pfizer, lot number: EN6198) via Intramuscular in Left arm on 04Mar2021 at 10: 45 at single dose for COVID-19 immunisation. Patient medical history included Gluten allergy. Concomitant medications included Phentermine, hydrochlorothiazide, ibuprofen. On 04Mar2021 at 16:00, patient had extreme pain in left side of neck with difficulty moving, gout-like reaction in feet, arm pain, fatigue, weakness, body aches, left hand knuckles swelled turned red stiff and painful, fainted, headache, vision disturbances, shakiness, dizziness. Adverse events was not resulted in Emergency room/department or urgent care. treatment was not given. No covid prior vaccination and no covid tested post vaccination. Outcome of events were not recovered.; Sender's Comments: Based on temporal assosciation, the causal relationship between BNT162B2 and the serious event, syncope cannot be completely ruled out.The impact of this report on benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.

Metallic taste strong at time of vaccine, every day afterwards sometimes with eating sometimes not with food; very vivid dreams every night-sometimes nightmares, usually don't remember dreaming at all; very vivid dreams every night-sometimes nightmares, usually don't remember dreaming at all; This is a spontaneous report from a contactable Other-HCP (patient reported herself). A 42-year-old non-pregnant female patient received BNT162B2 (COVID-19, Pfizer, Formulation: Solution for injection, Lot number: EL3247) via an unspecified route of administration on 29Jan2021 12:00 PM at single dose to her left arm for Covid-19 immunization. She was allergic to Sulfa-thrush. No Covid was tested prior or post vaccination. Concomitant medications included (BENADRYL) every night and paracetamol (TYLENOL) 1-2 times a week bef. On 29Jan2021, the patient experienced metallic taste strong at time of vaccine, every day afterwards sometimes with eating sometimes not with food, very vivid dreams every night-sometimes nightmares, usually did not remember dreaming at all. She did not take any treatment in response to the events. Outcome of the events was not recovered.

Vaccine 3/22/21, started with fatigue/generally feeling unwell 3/25/21, fever. Received Tdap vaccine 3/26/21. Persistent fever, pain around eye, ear and radiating into her head, nausea. Symptoms continued to worsen, developed chest pain and new onset seizure 3/31/21- Sent to ER for evaluation

Moderate pain at injection site. Severe sinus headache, pain in jaw, nausea and fatigue. Took Acetaminophen, drank lots of fluids and ate saltines and buttered toast, and took a nap. Started to feel better about 4PM.

Within minutes of receiving the vaccine, I felt tingling in my left arm at the shot injection site. About 20 mins later, I felt tingling and numbness in my upper lip as well as just above my lip. Consulted with the pharmacist who administered the shot as well as an on-line nurse about adverse side effect. I was instructed to take Benedryl, which I did (37.5 mg). It didn?t do anything to address the tingling. It has been four plus days since the vaccination and the right side of my upper lip feels swollen.

Began experiencing right side of tongue and lips tingling within 30 minutes after receiving vaccine. Took oral diphenhydramine but it did not improve. Visited urgent care the next day. No treatment was given, and patient was advised to follow up with primary physician. Four days later patient states she feels like her mouth is swollen on one side.

Within 5 or so minutes of injection - Waves of warmth and nausea. Very slight tingling in throat. Slightly elevated heart rate. Dehydration. Treated with benedryl and drank a lot of water and gatorade. Symptoms continued through next day. Body aches within 24 hours of vaccine in addition to tenderness at site of shot.

blood in my eye;This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received the second dose of BNT162B2 (BNT162B2, Lot number and expiry date were not reported), via an unspecified route of administration, administered in left arm on 26Feb2021 13:00 (at the age of 42-year-old) at single dose for COVID-19 immunization. The patient is not pregnant. Medical history included a leiden factor a blood disorder. The patient had no known allergies. Concomitant medications included ibuprofen (MOTRIN); ashwagandha; ascorbic acid (VITAMIN C); and an unspecified Pfizer vaccine on 12Mar2021 administered in the left arm. The patient previously received the first dose of BNT162B2 on unspecified date for COVID-19 immunization. On 11Mar2021 12:00 AM, the patient experienced blood in her eye. There was no treatment for the event. No COVID prior vaccination and was not tested with COVID post vaccination. The outcome of the event was recovering. Information about lot/batch number has been requested.